10-K: TG Therapeutics Soars on Briumvi Sales, Returns to Profitability

TG Therapeutics' 2025 annual report reveals robust revenue growth driven by BRIUMVI, achieving substantial net income and advancing its key pipeline assets.

Summary

• Net income for the year ended December 31, 2025, was $447.2 million, a significant increase from $23.4 million in 2024.
• Total revenue reached $616.3 million in 2025, up from $329.0 million in 2024, primarily driven by BRIUMVI sales.
• Net product revenue, predominantly from BRIUMVI, increased to $606.9 million in 2025 from $313.7 million in 2024.
• U.S. net product sales of BRIUMVI were $594.1 million in 2025, compared to $310.0 million in 2024.
• International sales of BRIUMVI to Neuraxpharm grew to $12.8 million in 2025 from $3.7 million in 2024.
• The accumulated deficit was significantly reduced to approximately $1.1 billion as of December 31, 2025, from $1.5 billion in 2024.
• The company completed a $100 million share repurchase program in September 2025, repurchasing 3,502,334 shares at an average price of $28.55 per share.
• A new $100 million share repurchase program was authorized in September 2025, with no repurchases under it by December 31, 2025.
• Enrollment commenced in the Phase 3 pivotal program for subcutaneous ublituximab in September 2025, and it was approximately 75% enrolled by February 2026.
• Enrollment was completed in the randomized cohort of the Phase 3 ENHANCE trial for a consolidated IV BRIUMVI dosing schedule in October 2025.
• The first patient with progressive multiple sclerosis was dosed with azer-cel in a Phase 1 trial in August 2025.
• License agreements for TG-1701 (BTK inhibitor) and TG-1801 (anti-CD47/anti-CD19) were mutually terminated in September 2025 and April 2025, respectively.

Sentiment

Score: 8

Explanation: StockSavvy.ai views this as a strong positive report, driven by exceptional revenue growth from BRIUMVI and a significant return to profitability, alongside continued pipeline advancement and shareholder return initiatives. While expenses increased and cash balances decreased due to share repurchases and R&D, the overall financial performance and strategic progress are highly favorable.

Positives

• Net income surged to $447.2 million in 2025, a substantial increase from $23.4 million in 2024, indicating strong profitability.
• Total revenue grew by 87.3% to $616.3 million in 2025, demonstrating robust commercial performance.
• Product revenue, net, primarily from BRIUMVI, nearly doubled to $606.9 million in 2025, reflecting successful market penetration.
• U.S. BRIUMVI sales increased by 91.6% to $594.1 million in 2025, highlighting strong domestic adoption.
• International BRIUMVI sales to Neuraxpharm significantly increased to $12.8 million in 2025, indicating growing ex-U.S. market presence.
• The accumulated deficit was reduced by over $447 million, from $1.5 billion to $1.1 billion, improving the company's financial health.
• Completion of a $100 million share repurchase program and authorization of a new $100 million program signals confidence in valuation and commitment to shareholder returns.
• Existing cash, cash equivalents, and investment securities, combined with projected future revenues, are anticipated to fund operations for more than twelve months.
• Advancement of the pipeline with Phase 3 enrollment for subcutaneous ublituximab (75% enrolled by February 2026) and Phase 1 dosing for azer-cel in progressive MS.
• Completion of enrollment in the Phase 3 ENHANCE trial for a simplified IV BRIUMVI dosing schedule, potentially enhancing market appeal.
• Long-term data from ULTIMATE I & II trials demonstrated 92% of RMS patients were free from disability progression after five years and 89.9% after six years, with very low annualized relapse rates (0.02 and 0.012 respectively), reinforcing BRIUMVI's efficacy and safety profile.
• Issuance of three additional patents for BRIUMVI extends patent protection through 2042, strengthening intellectual property.
• FDA clearance of the IND for azer-cel for progressive forms of MS in August 2024 opens a new therapeutic avenue.
• Effective internal control over financial reporting as of December 31, 2025, as audited by KPMG LLP, indicates strong financial governance.

Negatives

• License, milestone, royalty, and other revenue decreased to $9.4 million in 2025 from $15.3 million in 2024, primarily due to the recognition of a large upfront payment and milestone in prior periods.
• Cost of revenue increased significantly to $100.7 million in 2025 from $38.5 million in 2024, partly due to the depletion of pre-approval expensed inventory and a $6.2 million inventory reserve.
• Research and development expenses increased to $160.2 million in 2025 from $94.3 million in 2024, reflecting higher investment but impacting current period profitability.
• Selling, general, and administrative expenses rose to $232.0 million in 2025 from $154.3 million in 2024, driven by increased marketing and personnel costs for BRIUMVI commercialization.
• Net cash used in operating activities was $24.8 million in 2025, indicating continued cash burn from operations despite profitability.
• Cash and cash equivalents decreased significantly from $179.9 million in 2024 to $79.1 million in 2025.
• Net cash used in financing activities was $89.7 million in 2025, primarily due to stock repurchases, reducing overall cash reserves.
• Termination of two pipeline programs (TG-1701 and TG-1801) indicates a reduction in the breadth of the development portfolio.
• Reliance on single-source suppliers for critical materials (API/drug substance, raw materials) increases supply chain risk and potential for disruption.

Risks

• Failure to achieve broad market acceptance for BRIUMVI or future product candidates among physicians, patients, healthcare payors, and the medical community.
• Regulatory approvals for products may be subject to conditions, limitations on indicated uses, or requirements for costly post-marketing studies, potentially leading to labeling restrictions or withdrawal from the market.
• BRIUMVI or future approved products may cause undesirable side effects or adverse events after commercialization, leading to regulatory actions, product recalls, or product liability lawsuits.
• Market opportunities for BRIUMVI and product candidates may be smaller than estimated, or approvals may be based on narrower patient populations, adversely affecting revenue and profitability.
• Substantial competition from numerous pharmaceutical and biotechnology companies, many with greater resources and more advanced products, could reduce or eliminate commercial opportunities.
• BRIUMVI and future products may become subject to unfavorable pricing regulations or third-party payor coverage and reimbursement policies, including impacts from the Inflation Reduction Act and potential Most Favored Nation policies.
• Product liability lawsuits could cause substantial liabilities and limit commercialization efforts.
• Incurrence of substantial operating losses in the future, despite recent profitability, due to the speculative nature of biopharmaceutical development.
• Need for additional capital if current funding is insufficient, potentially delaying, limiting, reducing, or eliminating drug development programs or commercialization efforts.
• Level of indebtedness and debt service obligations could adversely affect financial condition and make it more difficult to fund operations.
• Inability to maintain or obtain regulatory approval for products or product candidates, or significant delays in doing so, could materially harm the business.
• Results of preclinical studies and early clinical trials may not be predictive of future results, and interim data may change, negatively impacting the perceived product profile.
• Biologics carry unique risks and uncertainties in development, manufacturing, and sale.
• Product candidates may cause undesirable side effects or adverse events, delaying or preventing regulatory approval or impacting commercial potential.
• Extensive, costly, and time-consuming regulation of clinical development and regulatory approval processes, leading to unanticipated delays.
• New legislation, regulatory proposals, and third-party payor initiatives may increase compliance costs and adversely affect the ability to market products, obtain collaborators, and raise capital.
• Inadequate funding, government shutdowns, workforce reductions, or other policy changes affecting regulatory agencies (FDA, SEC) could hinder their ability to perform normal business functions.
• Failure to adequately understand and comply with local laws and customs when expanding into new international markets.
• Products, even after marketing approval, could be subject to restrictions or withdrawal from the market due to non-compliance or unanticipated problems.
• Reliance on third parties to generate clinical, preclinical, and other data, and to conduct clinical trials, carries risks of non-performance or delays.
• Reliance on third-party contract manufacturers for clinical and commercial supply increases the risk of insufficient quantities, unacceptable cost/quality, or supply disruptions.
• Dependence on single-source suppliers for starting materials, intermediates, API/drug substance, and other materials, with risks of loss or disruption.
• Disputes with or non-performance by licensors could adversely affect the ability to develop and commercialize licensed products.
• Unsuccessful collaboration and commercialization partnerships, or termination of agreements, could negatively impact business and net product revenue generation.
• Inability to obtain and protect intellectual property and proprietary technologies, or challenges to the validity and enforceability of patents.
• Costly and time-consuming lawsuits to protect or enforce patents, or for alleged infringement of third-party intellectual property rights.
• Need to license certain intellectual property from third parties, which may not be available or on commercially reasonable terms.
• Failure to protect the confidentiality of trade secrets, harming business and competitive position.
• Potential for claims of wrongful use or disclosure of alleged trade secrets of competitors or breach of non-competition/non-solicitation agreements.
• Failure to attract and retain key management, commercial, and clinical development personnel.
• Difficulties in managing business development and expansion, including integrating acquisitions or strategic alliances.
• Certain anti-takeover provisions in governing documents and Delaware law could make a third-party acquisition difficult, potentially limiting stock price.
• Ability to utilize net operating loss (NOL) carryforwards and certain other tax attributes may be limited by ownership changes.
• Significant influence of executive officers, directors, principal stockholders, and their affiliates over the company.
• Vulnerability of internal information technology systems, or those of third-party contractors, to failures or security breaches, including from AI-driven attacks, resulting in disruption, financial loss, or reputational harm.
• Unfavorable global economic conditions and changes in government regulations (e.g., tariffs, BIOSECURE Act) could adversely affect business, financial condition, or results of operations.
• Stock price volatility, limiting investors' ability to sell stock at a profit.
• Risks related to corporate social responsibility and reputational matters, including ESG concerns.
• Climate change or legal/regulatory/market measures to address climate change may negatively affect business and supply chain.
• Limitations on the ability to pay dividends due to current debt agreements.
• An active trading market for common stock may not be sustained.
• If equity research analysts do not publish research or publish negative evaluations, the stock price could decline.
• Significant increased costs and management time required for public company compliance.
• Securities and shareholder derivative litigation due to stock price volatility.
• Future sales of common stock, including by the company or insiders, could cause the stock price to decline.
• The share repurchase program may not be further consummated or enhance stockholder value, and could be suspended or terminated.

Future Outlook

The company anticipates that its existing cash, cash equivalents, investment securities, and projected future revenues will be sufficient to fund operations and meet liquidity needs for more than twelve months. It expects to continue incurring significant research and development expenses, as well as commercialization and outsourced manufacturing expenses, as it expands BRIUMVI's market adoption, develops subcutaneous ublituximab, optimizes intravenous BRIUMVI, and evaluates BRIUMVI in other autoimmune diseases and azer-cel for progressive MS. The company may seek significant additional financing to support strategic initiatives and ongoing operations and will continue to evaluate in-licensing and acquisition opportunities. Cost of revenue and gross margin are expected to normalize after the depletion of pre-approval expensed inventory, and a new sublease agreement is expected to significantly reduce net rent expense prospectively.

Management Comments

• We believe BRIUMVI's clinical profile, including its one-hour infusion time and twice-annual dosing schedule, together with demonstrated efficacy and safety in pivotal trials and accumulating real-world experience, supports its positioning within the anti-CD20 therapeutic class.
• Our ability to expand adoption is dependent on continued execution across access and site-of-care pathways.
• We believe that our future success largely depends upon our continued ability to attract and retain a diverse workforce of highly skilled and dedicated employees.
• We pride ourselves on being an equal opportunity employer and strictly prohibit unlawful discrimination based on color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
• We expect to continue to grow our organization to support the commercialization of BRIUMVI and to enhance our overall development capabilities for current or future products under development.
• Risks from cybersecurity threats have not materially affected us to date and, based on management's current assessment, are not reasonably likely to materially affect us, our business strategy, results of operations or financial condition.
• Our management has concluded that, as of December 31, 2025, our internal control over financial reporting was effective based on these criteria.

Industry Context

StockSavvy.ai notes that TG Therapeutics operates in the highly competitive biotechnology and biopharmaceutical market, particularly within the neurological and immunological fields. The company's focus on B-cell mediated diseases, including Multiple Sclerosis, places it in direct competition with major pharmaceutical players like Roche Holdings AG (ocrelizumab) and Novartis AG (ofatumumab). The market is also seeing the emergence of new classes of therapies, such as Bruton's tyrosine kinase (BTK) inhibitors and CD40 ligand (CD40L) targeting therapies, which could alter treatment paradigms and increase competitive pressure on existing anti-CD20 monoclonal antibodies like BRIUMVI. The company's strategy to develop a subcutaneous formulation of ublituximab aligns with industry trends towards more convenient patient administration, aiming to compete more effectively with self-administered therapies. The termination of two pipeline programs (TG-1701 and TG-1801) suggests a strategic re-prioritization towards more promising assets like azer-cel and the subcutaneous ublituximab, a common practice in the high-risk, high-reward drug development industry. The increasing regulatory scrutiny on drug pricing and the impact of legislation like the Inflation Reduction Act and potential Most Favored Nation policies reflect broader industry challenges in maintaining profitability and market access.

Comparison to Industry Standards

• BRIUMVI directly competes with ocrelizumab (Roche Holdings AG), an intravenously administered anti-CD20 monoclonal antibody, and a subcutaneous version of ocrelizumab.
• BRIUMVI also competes with ofatumumab (Novartis AG), a patient/self-administered subcutaneous anti-CD20 monoclonal antibody. The development of subcutaneous ublituximab aims to directly compete with self-administered therapies like ofatumumab.
• The annualized relapse rate (ARR) of 0.02 after five years and 0.012 after six years for BRIUMVI in ULTIMATE I & II trials demonstrates strong efficacy, comparable to or potentially superior to some existing MS therapies.
• The one-hour infusion time every 24 weeks for IV BRIUMVI is a competitive advantage in convenience compared to other IV therapies.
• The 92% freedom from disability progression after five years and 89.9% after six years for BRIUMVI in RMS patients is a strong clinical outcome in a competitive landscape.

Corporate Governance

Related Party Transactions

• The company incurred expenses of approximately $1.2 million, $1.3 million, and $0.9 million for shared services under a Shared Services Agreement with Fortress Biotech, Inc. (FBIO) for the years ended December 31, 2025, 2024, and 2023, respectively. These services include facilities use, personnel costs, and other overhead.
• Michael S. Weiss, the company's Chairman and Chief Executive Officer, also serves as a director and Executive Vice Chairman, Strategic Development of FBIO.
• The company has an Office Agreement with FBIO to occupy approximately 45% of 24,000 square feet of New York City office space leased by FBIO, with an estimated average annual rental obligation of $1.8 million. A sublease agreement for the entirety of this space was entered into by FBIO in February 2026, which is expected to significantly reduce the company's net rent expense prospectively.

Stakeholder Impact

• Shareholders are positively impacted by strong revenue growth, significant return to profitability, and ongoing share repurchase programs, which can enhance shareholder value. However, potential future equity capital raises could lead to dilution.
• Patients benefit from the successful commercialization of BRIUMVI for RMS and the continued development of subcutaneous ublituximab and azer-cel for other B-cell diseases and progressive MS, offering new treatment options.
• Employees are positively impacted by the company's growth, which supports headcount expansion, and by equity compensation awards, although the competitive landscape for talent remains intense.
• Customers, including healthcare providers and payors, are impacted by the increasing market penetration of BRIUMVI, but also face evolving competitive dynamics, pricing regulations, and reimbursement policies.
• Suppliers and contract manufacturers continue to be key partners, but face risks related to supply chain disruptions, quality control, and compliance with cGMP regulations.
• Creditors, particularly those involved in the $250 million term loan, are in a stable position as the company is in compliance with all financial covenants.

Next Steps

• Continue commercializing BRIUMVI in the U.S. and ex-U.S. markets.
• Submit for FDA approval a simplified dosing schedule for IV BRIUMVI in the U.S. based on the ENHANCE trial.
• Evaluate other uses for BRIUMVI in additional MS indications and/or other autoimmune diseases.
• Develop and seek FDA approval of a subcutaneous form of BRIUMVI (ublituximab).
• Identify additional areas to expand the use of BRIUMVI beyond MS.
• Continue to expand the pipeline with mechanisms of importance to B-cell mediated diseases.
• Evaluate the potential of azer-cel to treat patients with B-cell mediated diseases, including progressive forms of multiple sclerosis.
• Maintain a patient-first culture as the business grows.
• Continue to monitor proposed cybersecurity disclosure rules from the SEC and alter procedures accordingly.
• Potentially seek additional financing to support strategic initiatives and ongoing/planned operations.
• Continue share repurchases under the new $100 million program.
• Complete enrollment and trials for subcutaneous ublituximab.

Key Dates

Recommendation

The company demonstrated exceptional financial performance in 2025, with a substantial increase in product revenue from BRIUMVI and a significant return to net profitability. The reduction in accumulated deficit and sufficient liquidity for the next 12+ months indicate a strong financial position. Pipeline advancements, particularly the subcutaneous ublituximab and azer-cel, offer future growth potential. The ongoing share repurchase program signals confidence in the company's valuation and commitment to shareholder returns. While R&D and SG&A expenses increased, they reflect investment in commercialization and pipeline, which is appropriate for a growth-stage biotech. The long-term efficacy and safety data for BRIUMVI further solidify its market position.

Keywords

Biotechnology, Multiple Sclerosis, BRIUMVI, Ublituximab, Relapsing Forms of Multiple Sclerosis, Autoimmune Diseases, Azer-cel, CAR T cell therapy, Clinical Trials, FDA Approval, Commercialization, Drug Development, Financial Results, Share Repurchase, SEC Filing, Corporate Governance, Risk Management, Cybersecurity, Healthcare Regulation, Neuraxpharm, Precision BioSciences, Nasdaq Capital Market