TG THERAPEUTICS, INC. (TGTX)

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis contains forward-looking statements about our plans and expectations of what may happen in the future. Forward-looking statements are based on a number of assumptions and estimates that are inherently subject to significant risks and uncertainties, and our results could differ materially from the results anticipated by our forward-looking statements as a result of many known or unknown factors, including, but not limited to, those factors discussed in “Risk Factors.” See also the “Special Cautionary Notice Regarding Forward-Looking Statements” set forth at the beginning of this report.

You should read the following discussion and analysis in conjunction with the condensed consolidated financial statements and the related footnotes thereto appearing elsewhere in this report, and in conjunction with management’s discussion and analysis and the audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2025.

OVERVIEW

TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI (ublituximab-xiiy) to treat adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval from several regulatory agencies outside of the U.S. for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities.

RECENT EVENTS

ENHANCE Phase 3 Trial in RMS

In May 2026, we announced positive topline results from the Phase 3 ENHANCE trial, a randomized, double-blind study evaluating a consolidated single infusion regimen for initiation of BRIUMVI® (ublituximab-xiiy) in adults with relapsing forms of multiple sclerosis (RMS). The trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved BRIUMVI initiation infusion dosing regimen of 150 mg on Day 1 and 450 mg on Day 15 and a consolidated single 600 mg infusion on Day 1, eliminating the need for a Day 15 infusion.

Subcutaneous BRIUMVI in RMS

In June 2026, we announced positive pharmacokinetic (PK), pharmacodynamic (PD), safety, and tolerability data from the Phase 1 clinical trial evaluating subcutaneous formulation of ublituximab (the active agent in BRIUMVI®). The PK and PD data from the Phase 1 clinical trial support quarterly subcutaneous BRIUMVI dosing regimen which is currently under evaluation in the fully enrolled Phase 3 trial. Topline data from the Phase 3 trial is expected around year-end 2026 or first quarter 2027.

BRIUMVI in Myasthenia Gravis

In June 2026, we announced positive topline data from our Phase 1 clinical trial for BRIUMVI in patients with myasthenia gravis (MG) and the initiation of a Phase 2 clinical trial evaluating BRIUMVI as a maintenance therapy following induction with efgartigimod in adult patients with MG.

BRIUMVI in Schizophrenia

In July 2026, we announced the initiation of a Phase 2 clinical trial evaluating BRIUMVI in adults with treatment-resistant schizophrenia.

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OUR PRODUCTS

We currently license worldwide development and commercial rights, subject to certain limited geographical restrictions, for all of our products under development. The following table summarizes select ongoing and planned clinical development programs for our lead drug candidates as of July 2026.

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BRIUMVI (ublituximab-xiiy) Overview

Development of BRIUMVI

BRIUMVI is an anti-CD20 monoclonal antibody that can be administered to adults with RMS in a one-hour infusion every 24 weeks, following the starting dose. BRIUMVI received approval from the FDA primarily based on results from the ULTIMATE I and ULTIMATE II Phase 3 trials. Each trial was an independent global, randomized, multi-center, double-blinded, double-dummy, active-controlled study comparing the efficacy and safety/tolerability of BRIUMVI (450mg dose administered by one-hour intravenous infusion every 6 months, following a day 1 infusion of 150mg over four hours and a day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in adult subjects with RMS.

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U.S. Commercialization of BRIUMVI and Market Dynamics

BRIUMVI (ublituximab-xiiy), an anti-CD20 monoclonal antibody indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, was approved by the U.S. Food and Drug Administration (FDA) in December 2022 and commercially launched in the United States in January 2023. BRIUMVI is administered as a one-hour, twice per year infusion following the starting dose. Since launch, our commercialization efforts have focused on expanding prescriber awareness, increasing penetration across infusion centers and neurology practices, securing payer coverage, and supporting patient access within a competitive RMS treatment landscape.

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. The anti-CD20 class represents a significant segment of the RMS market, reflecting physician familiarity with the mechanism of action and long-term treatment considerations. Our ability to expand adoption is dependent on continued execution across access and site-of-care pathways; however, uptake may be influenced by factors including established prescribing practices, patient switching dynamics, payer coverage and utilization management requirements, competitive contracting, site-of-care logistics, and evolving treatment guidelines.

The RMS market is highly competitive and includes numerous approved disease-modifying therapies with varying mechanisms of action, routes of administration, safety profiles, and dosing schedules. Competitive dynamics may be influenced by pricing and contracting strategies, payer utilization management practices, the introduction of new branded products or biosimilars, and broader healthcare system and macroeconomic conditions. Our ability to continue to grow BRIUMVI revenues will depend on sustained physician adoption, patient persistence and adherence, competitive differentiation within the anti-CD20 class, and continued access across commercial and government payers.

Our net product revenue is subject to gross-to-net adjustments, including mandatory government discounts and rebates, contractual rebates and chargebacks, trade discounts and allowances (including cash discounts), product returns, distribution fees, and patient support programs. These adjustments are influenced by payer and site of care mix, coverage determinations, contracting dynamics, and patient assistance utilization, and may fluctuate from period to period. As our commercial footprint expands and payer contracting strategies evolve, the magnitude and variability of these adjustments may change.

Ex-U.S. Commercialization of BRIUMVI

In June 2023, we announced that the EC granted approval of BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. With this approval, the centralized marketing authorization is valid in all EU member states, Iceland, Norway and Liechtenstein.

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In August 2023, we announced an agreement with Neuraxpharm Pharmaceuticals, S.L. (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of CNS disorders, for the Ex-U.S. commercialization of BRIUMVI (Commercialization Agreement). Under the terms of the Commercialization Agreement, we received an upfront payment of $140 million, and $12.5 million upon launch in the first EU country in February 2024, and up to an additional $492.5 million in milestone-based payments on achievement of certain launch and commercial milestones. The total deal is valued at up to $645 million in upfront and milestone payments. In addition, we will receive tiered double-digit royalties on net product sales up to 30%. In exchange, Neuraxpharm will have the exclusive right to commercialize BRIUMVI in territories outside the U.S., Canada and Mexico, which are retained by TG, and excluding certain Asian countries of which we previously partnered.

In February 2024, we announced the commercial launch of BRIUMVI in the EU by Neuraxpharm, with BRIUMVI made available for commercial sale in Germany.

BRIUMVI is now approved in the Europe

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ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

The following discussion and analysis contains forward-looking statements regarding our business, operations, financial condition, and prospects. Forward-looking statements are based on various assumptions and estimates that are inherently subject to significant risks and uncertainties, and our results could differ materially from those anticipated as a result of many known or unknown factors, including, but not limited to, those factors discussed in “Risk Factors.” See also the “Special Cautionary Notice Regarding Forward-Looking Statements” included at the beginning of this Annual Report on Form 10-K.

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You should read the following discussion and analysis in conjunction with “Item 8. Financial Statements and Supplementary Data,” and our consolidated financial statements beginning on page F-1 of this report.

Overview

TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI (ublituximab-xiiy) to treat adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval from several regulatory agencies outside of the U.S. for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities.

Commercial Launch and Market Dynamics

BRIUMVI (ublituximab-xiiy), an anti-CD20 monoclonal antibody indicated for the treatment of relapsing forms of multiple sclerosis (RMS), was approved by the U.S. Food and Drug Administration (FDA) in December 2022 and commercially launched in the United States in January 2023. BRIUMVI is administered as a one-hour, twice per year infusion following the starting dose. Since launch, our commercialization efforts have focused on expanding prescriber awareness, increasing penetration across infusion centers and neurology practices, securing payer coverage, and supporting patient access within a competitive RMS treatment landscape.

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. The anti-CD20 class represents a significant segment of the RMS market, reflecting physician familiarity with the mechanism of action and long-term treatment considerations. Our ability to expand adoption is dependent on continued execution across access and site-of-care pathways; however, uptake may be influenced by factors including established prescribing practices, patient switching dynamics, payer coverage and utilization management requirements, competitive contracting, site-of-care logistics, and evolving treatment guidelines.

In August 2023, we entered into a Commercialization Agreement with Neuraxpharm Pharmaceuticals, S.L. (Neuraxpharm), pursuant to which Neuraxpharm obtained rights to commercialize BRIUMVI outside the United States. Under the agreement, we are eligible to receive milestone payments, royalties and revenue from product supply to Neuraxpharm. The timing and magnitude of ex-U.S. revenues depend on country-specific regulatory approvals, pricing and reimbursement determinations, launch timing, and commercial uptake. We provide development, regulatory, and other support services as required under the agreement to facilitate commercialization activities in applicable territories.

The RMS market is highly competitive and includes numerous approved disease-modifying therapies with varying mechanisms of action, routes of administration, safety profiles, and dosing schedules. Competitive dynamics may be influenced by pricing and contracting strategies, payer utilization management practices, the introduction of new branded products or biosimilars, and broader healthcare system and macroeconomic conditions. Our ability to continue to grow BRIUMVI revenues will depend on sustained physician adoption, patient persistence and adherence, competitive differentiation within the anti-CD20 class, and continued access across commercial and government payers.

Our net product revenue is subject to gross-to-net adjustments, including mandatory government discounts and rebates, contractual rebates and chargebacks, trade discounts and allowances (including cash discounts), product returns, distribution fees, and patient support programs. These adjustments are influenced by payer mix, coverage determinations, contracting dynamics, and patient assistance utilization, and may fluctuate from period to period. As our commercial footprint expands and payer contracting strategies evolve, the magnitude and variability of these adjustments may change.

Pipeline and Lifecycle Management

In addition to the ongoing commercialization of BRIUMVI, we continue to invest in our commercial organization, infrastructure, and internal capabilities to support lifecycle management and potential expansion of the product’s clinical and commercial profile. A key area of focus is the development of a subcutaneous formulation of ublituximab, which is being evaluated as a potential alternative route of administration that may offer increased convenience and flexibility for patients and healthcare providers. We are also exploring the use of BRIUMVI in autoimmune indications outside of MS and are advancing early-stage development activities for azer-cel in autoimmune diseases. These programs reflect our broader strategy to enhance the durability of our portfolio and expand future therapeutic opportunities.

Beyond BRIUMVI, we continue to evaluate potential in-licensing and acquisition opportunities. These opportunities may include earlier-stage programs, complementary products, proprietary technologies, or other therapeutic approaches that could enhance our pipeline and support long-term growth. The scope, timing, and level of any such investments will depend on a range of factors, including scientific and clinical data, manufacturing feasibility, regulatory considerations, commercial readiness, available resources, and overall strategic and financial priorities.

Financial Overview and Key Components of our Operating Results

Although we have recently achieved profitability, we have historically incurred substantial operating losses since our inception and may continue to experience fluctuations in operating results. Despite the commercialization of BRIUMVI and the potential future commercialization of other product candidates, there can be no assurance that we will maintain profitability on an ongoing basis.

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For the twelve months ended December 31, 2025, we generated revenue of $616.3 million. Historically, our operating losses have been driven primarily by expenses related to research and development programs and selling, general and administrative costs associated with our operations and commercialization activities to date. Our operating results and cash flows have fluctuated in the past and may continue to vary significantly from period to period. We will need to generate substantial revenues to sustain profitability and positive cash flow over the long term.

As of December 31, 2025, our accumulated deficit was approximately $1.1 billion, and we had $199.5 million in cash and cash equivalents, and investment securities. Based on our current operating plan and results, we anticipate that our existing cash, cash equivalents, and investment securities, together with projected future revenues, will be sufficient to fund operations and meet our liquidity needs for more than twelve months after the date of issuance of this Annual Report on Form 10-K.

The actual level of cash required for operations will depend on numerous factors, including, among others, the scope of commercialization activities for BRIUMVI, the timing of collection of receivables from our customers on extended payment terms, the timing and design of clinical trials for our product candidates, and the costs associated with licensing or acquiring new product candidates. We may seek significant additional financing in the future to support strategic initiatives and our ongoing and planned operations.

We expect our expenses to increase as we continue to grow and expand our clinical programs and pursue the potential commercialization of additional product candidates. We anticipate incurring significant research and development expenses related to these activities for the foreseeable future. The actual amount of cash needed to support these strategic initiatives will depend on many factors, including:

Cost of Revenue

Cost of revenue consists primarily of royalties owed to our licensing partner for BRIUMVI sales, materials and third-party manufacturing costs, freight, distribution and logistics expenses, and overhead costs associated with our supply chain. Cost of revenue may also include excess or obsolete inventory adjustments, abnormal manufacturing costs, unabsorbed overhead, and manufacturing variances.

In accordance with our policy to expense costs associated with the manufacture of our products prior to regulatory approval, a portion of the manufacturing costs incurred to produce BRIUMVI before its FDA approval in December 2022 were expensed to research and development. As a result, a portion of the BRIUMVI units recognized as revenue during the years ended December 31, 2025, 2024 and 2023 are not included in the cost of product revenue during those periods.​

As commercialization continues and pre-approval inventory has been fully depleted, we expect cost of revenue and gross margin to normalize to levels that reflect current commercial manufacturing costs, royalty payments, and supply chain expenses. Period-over-period fluctuations in cost of revenue may continue to occur based on the nature of our ordinary course of business operations, including production scheduling, manufacturing, inventory management, and the timing of overhead allocation.

Research and Development (R&D) Expenses (Other)

Our other research and development expenses consist primarily of external clinical and manufacturing costs, personnel-related expenses, milestone and licensing payments, and overhead costs supporting development activities. We recognize R&D costs as incurred. T

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