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Item 2 — Management's Discussion and Analysis
Tg Therapeutics, Inc. · 10-Q · Q2 FY2026 · Period ended Jun 30, 2026
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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.
Clinical Drug Candidate: (molecular target) Disease Stage/Status of Development
BRIUMVI (anti-CD20 mAb) RMS APPROVED
BRIUMVI (simplified dosing) ENHANCE Trial RMS Phase 3 completed enrollment and positive topline Phase 3 data announced
BRIUMVI Myasthenia Gravis Phase 2 enrolling
BRIUMVI Schizophrenia Phase 2 enrolling
Ublituximab subcutaneous (anti-CD20 mAb) RMS Phase 3 completed enrollment
Azer-cel (anti-CD19) Progressive Forms of Multiple Sclerosis and B-cell Disorders Phase 1 enrolling
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.
● In December 2020, we announced positive top-line results from the ULTIMATE I & II trials. Both studies met their primary endpoint of significantly reducing ARR over a 96-week period (p<0.005 in each study) with BRIUMVI demonstrating an ARR of <0.10 in each of the studies. Relative reductions of approximately 60% and 50% in ARR over teriflunomide were observed in ULTIMATE I & II, respectively. Key secondary MRI endpoints were also met.
● On August 22, 2022, the full results from the ULTIMATE I & II trials were published in the New England Journal of Medicine.
● On December 28, 2022, we announced the U.S. Food and Drug Administration (FDA) approved BRIUMVI for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
● On February 27, 2024, we announced the issuance of three additional patents by the United States Patent and Trademark Office (USPTO) for BRIUMVI, which extended patent protection through 2042.
● In February 2026, five-year data from the ongoing open label extension (OLE) of the Phase 3 ULTIMATE I and II studies were published in JAMA Neurology.
● 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 in adults with relapsing forms of multiple sclerosis (RMS). The trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved 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.
● In June 2026, data from a post-hoc pooled analysis of the Phase 3 ULTIMATE I and II studies evaluating BRIUMVI in treatment-naïve adult patients with RMS was published in Frontiers in Immunology.
● 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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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 European Union, the United Kingdom, Switzerland, Australia, Kuwait, the United Arab Emirates, Israel, Saudi Arabia and Brazil.
Subcutaneous Ublituximab Overview
In August 2024, we announced the initiation of a Phase 1 clinical trial evaluating subcutaneous ublituximab (the active ingredient in BRIUMVI), and sometimes otherwise referred to as “subcutaneous BRIUMVI" in patients with RMS.
In January 2025, we announced the first patients with myasthenia gravis (MG) had been enrolled in a clinical trial evaluating subcutaneous ublituximab.
In September 2025, we announced enrollment commenced in the Phase 3 pivotal program evaluating subcutaneous ublituximab. The Phase 3 pivotal program is a randomized, open label, parallel-group, multicenter study designed to evaluate the pharmacokinetics, pharmacodynamics, safety, radiological and clinical effects of subcutaneous ublituximab compared to IV BRIUMVI in adult participants with RMS. Participants were randomized into one of three arms: 8-week regimen of subcutaneous ublituximab, 12-week regimen of subcutaneous ublituximab or the currently approved IV BRIUMVI dosing schedule. The primary endpoint of the trial is to demonstrate non-inferior exposure of subcutaneous ublituximab compared to IV BRIUMVI as measured by area under the curve (AUC) at week 24. In April 2026, we announced the trial completed enrollment and topline data is expected around year-end 2026 or first quarter 2027.
In June 2026, we announced positive PK, PD, safety, and tolerability data from a Phase 1 clinical trial evaluating a high-concentration (400 mg/2 mL) subcutaneous ublituximab as compared to IV BRIUMVI. Over 100 patients had been treated in the trial, including more than 80 patients who received subcutaneous BRIUMVI across multiple dose levels (50 mg – 400 mg) in single and multiple dose cohorts. More than 225 subcutaneous injections of BRIUMVI were administered, of which over 75% were 400 mg (2 mL) injections. Key data highlights included:
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Bioavailability/Pharmacokinetics (Drug Exposure):
● The overall concentration-time profile of subcutaneous BRIUMVI was consistent with expectations for a subcutaneous formulation, with a gradual absorption phase and lower peak concentrations relative to IV, and linear pharmacokinetics were observed over the entire dose range evaluated.
● Subcutaneous BRIUMVI demonstrated mean bioavailability of greater than 60% relative to IV administration, with the lower bound of the 95% confidence interval exceeding 55%.
● PK modeling and simulation informed by the Phase 1 bioavailability data support the conclusion that:
o The quarterly subcutaneous dosing regimen that is being evaluated in the Phase 3 trial would achieve non-inferior total drug exposure over 24 weeks (AUC 0-Wk24) with an estimated geometric mean ratio (GMR) of 1.21 (with a lower bound of the 90% confidence interval at 1.15), as compared to IV BRIUMVI
o The every other month subcutaneous dosing regimen that is also being evaluated in the Phase 3 trial, would achieve non-inferior total drug exposure over 24 weeks (AUC 0-Wk24) with an estimated GMR of 1.58 (with a lower bound of the 90% confidence interval at 1.50), as compared to IV BRIUMVI
o The lower bound of the 90% confidence intervals for both dosing regimens being evaluated in Phase 3 would exceed the threshold required to establish non-inferiority (>0.80), which is the primary endpoint of the ongoing Phase 3 trial.
Pharmacodynamics (Biologic Activity):
● Treatment with subcutaneous BRIUMVI resulted in B-cell depletion consistent with IV BRIUMVI, supporting the biological activity of the subcutaneous formulation.
Safety & Tolerability:
● Subcutaneous administration was generally well tolerated, with treatment-emergent adverse events (TEAEs) consistent with the known safety profile of IV BRIUMVI.
● Local injection-site reactions were infrequent, occurring in less than 5% of patients, and systemic injection-related reactions occurred in approximately 21% of patients. Local and systemic injection reactions were not dose dependent and predominantly occurred at the first injection and resolved in 100% of patients.
● No serious injection-site reactions and no new safety signals were observed.
In June 2026, we announced positive topline data from an ongoing Phase 1 clinical trial evaluating subcutaneous BRIUMVI in patients with AChR-antibody-positive MG. 11 patients were treated across cohorts that demonstrated subcutaneous BRIUMVI exposure at least equivalent to the approved IV BRIUMVI regimen. Key data highlights included:
● Consistent reductions from baseline were observed across all myasthenia gravis outcome measures over time following treatment with subcutaneous BRIUMVI
● At Week 24, 82% of patients achieved the Minimal Clinically Important Difference (MCID) in MG-ADL, defined as a decrease of ≥ 2, with a median time to MCID of 30 days
● Overall, a mean 4.6 point improvement in MG-ADL was observed at Week 24
● Subcutaneous BRIUMVI was generally well tolerated, with a safety profile appearing consistent with the established safety profile of IV BRIUMVI in patients with multiple sclerosis
Azercabtagene Zapreleucel (azer-cel)
Azer-cel is an allogeneic (off-the-shelf) CD19-directed CAR T cell therapy under development by us for autoimmune diseases. Made from donor-derived T cells modified using a proprietary ARCUS genome editing technology, azer-cel recognizes the well characterized B-cell surface protein CD19, an important and validated target in several B-cell cancers and autoimmune diseases. Azer-cel is designed to minimize graft-versus-host disease (GvHD), a significant complication associated with other donor-derived, cell-based therapies.
In August 2024, we announced FDA clearance of the IND for azer-cel for the treatment of progressive forms of MS.
In August 2025, we announced the first patient with progressive multiple sclerosis had been dosed with azer-cel in a Phase 1 trial. The Phase 1 trial has now been expanded to include patients with other B-cell disorders.
For more information, please refer to our Annual Report on Form 10-K for the quarter and year ended December 31, 2025.
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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.
For the six months ended June 30, 2026, we generated revenue of $445.3 million and generated operating income and positive cash flows from operations. We will continue to invest in our research and development programs and in selling, general and administrative activities to support our commercialization efforts, while maintaining discipline around overall expense growth relative to revenue. 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 June 30, 2026, our accumulated deficit was approximately $1.1 billion, and we had $612.3 million in cash and cash equivalents, and investment securities, excluding equity investments. 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 filing of this Quarterly Report on Form 10-Q.
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 do not currently expect to need to raise additional capital to fund our ongoing operations, but may from time to time seek additional financing to support strategic initiatives, including potential business development activities.
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:
● the timing and success of the ongoing commercialization of BRIUMVI and any other products for which we receive regulatory approval;
● the costs and timing of clinical and commercial manufacturing supply arrangements for each product and product candidate;
● the costs of expanding our sales, distribution, and other commercialization capabilities;
● the costs and timing of regulatory approvals;
● the progress of our clinical trials, including expenses to support the trials and milestone payments that may become payable under our license agreements;
● our ability to establish and maintain strategic collaborations, including licensing and other arrangements;
● the costs involved in enforcing or defending patent claims or other intellectual property rights; and
● the extent to which we in-license or invest in other indications or product candidates.
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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 three months ended March 31, 2025 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. These expenses include:
● External development costs, including amounts paid to contract research organizations (CROs), contract manufacturing organizations (CMOs), central laboratories, clinical trial sites, and other third-party service providers supporting our preclinical studies, clinical trials, process development and analytical testing;
● Manufacturing and scale-up costs, including costs associated with producing preclinical and clinical supply and performing process development and optimization activities. Prior to FDA approval of BRIUMVI, all manufacturing costs for ublituximab were expensed to R&D as incurred. Following approval, manufacturing costs related to commercial supply are capitalized as inventory;
● Personnel and employee-related expenses, including salaries, benefits, travel and share-based compensation for employees engaged in research, clinical development, medical, regulatory and manufacturing-support functions;
● Milestone, licensing and collaboration expenses, including upfront payments and milestone obligations incurred under in-license and collaboration agreements; and
● Facility and other overhead costs that support research and development activities.
Selling, General, and Administrative (SG&A) Expenses (Other)
Our other selling, general and administrative expenses consist primarily of expenses related to the commercialization of our approved products and the expenses required to maintain and support a growing commercial organization. These expenses include:
● Commercial operations costs, including salaries and related expenses, benefits, incentives, share-based compensation and travel for sales, marketing, and commercial development team, as well as promotional programs, marketing initiatives, medical affairs, and reimbursement support services related to BRIUMVI;
● Corporate and administrative personnel costs, including salaries, benefits, travel and share-based compensation for executive, finance, accounting, business development, legal, human resources, and other administrative functions;
● Professional fees, including legal services, patent-related costs associated with the protection and maintenance of our intellectual property and propriety technologies, accounting and audit services, consulting services, external legal advisors, and other external advisors supporting our operations;
● Corporate infrastructure and facilities costs, including rent, utilities, insurance, information technology systems, and other overhead necessary for our day to day operations and to support our commercial and administrative activities;
● Additional SG&A support functions, such as medical affairs, legal activities, market access, reimbursement operations, and compliance.
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RESULTS OF OPERATIONS
The following table summarizes the results of operations for the three months ended June 30, 2026 and 2025:
Three months ended
June 30,
(in thousands) 2026 2025 Change
Product revenue, net $ 235,794 138,843 96,951
License, milestone, royalty and other revenue 4,541 2,305 2,236
Total Revenue $ 240,335 $ 141,148 $ 99,187
Costs and expenses:
Cost of revenue 41,194 18,938 22,256
Research and development:
Stock-based compensation 8,070 4,318 3,752
Other research and development 87,267 27,464 59,803
Total research and development 95,337 31,782 63,555
General and administrative:
Stock-based compensation 19,805 12,044 7,761
Other selling, general and administrative 62,325 43,541 18,784
Total general and administrative 82,130 55,585 26,545
Total costs and expenses 218,661 106,305 112,356
Interest expense 16,572 6,716 9,856
Other income (5,132 ) (2,793 ) (2,339 )
Total other expense 11,440 3,923 7,517
Net income before taxes 10,234 30,920 (20,686 )
Income tax expense (2,453 ) (2,733 ) 280
Net income $ 7,781 $ 28,187 $ (20,406 )
Product Revenue, Net. Product revenue, net was approximately $235.8 million for the three months ended June 30, 2026, compared to $138.8 million for the three months ended June 30, 2025. Product revenue, net for both the three months ended June 30, 2026 and June 30, 2025 consisted of net product sales of BRIUMVI in the United States of $227.7 million and $138.8 million, respectively. Also included in product revenue, net for the three months ended June 30, 2026 is sales of BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, of $8.1 million. The increase in product revenue, net is a result of greater market penetration of BRIUMVI in the United States and from commercial product sales supplied to Neuraxpharm under the Commercialization Agreement.
License, Milestone, Royalty and Other Revenue. License, milestone, royalty and other revenue was $4.5 million for the three months ended June 30, 2026 and $2.3 million for the three months ended June 30, 2025. License, milestone, royalty and other revenue for the three months ended June 30, 2026 is comprised of $3.6 million of royalty revenue recognized under the Commercialization Agreement with Neuraxpharm and $0.9 million of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement (see Note 2 – Revenue for more information).
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Cost of Revenue. Cost of revenue for the three months ended June 30, 2026 was $41.2 million compared to approximately $18.9 million for the three months ended June 30, 2025. Cost of revenue for both periods consisted primarily of royalties owed to our licensing partner for BRIUMVI sales, as well as third-party manufacturing, distribution and overhead costs. The increase was primarily driven by growth in BRIUMVI U.S. sales volume and sales to our ex-U.S. licensing partner, Neuraxpharm, during the three months ended June 30, 2026. There were no sales to Neuraxpharm during the three months ended June 30, 2025. Gross margin on BRIUMVI U.S. net product revenue remained approximately 87% during the three months ended June 30, 2026. Total gross margin was approximately 83%, reflecting the impact of sales to Neuraxpharm and other revenue sources, which carry different margins than BRIUMVI U.S. net product revenue.
Stock-Based Compensation Expense (Research and Development). Stock-based compensation expense (research and development) related to equity incentive grants and liability-classified awards totaled $8.1 million for the three months ended June 30, 2026, as compared to $4.3 million during the comparable period ended June 30, 2025. The increase in stock-based compensation expense for the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, was primarily due to the mark-to-market impact on stock tracking units, an increase in headcount, and greater recognition of stock-based compensation expense for performance and market-based awards.
Other Research and Development Expense. Other research and development expense was $87.3 million for the three months ended June 30, 2026, as compared to $27.5 million during the three months ended June 30, 2025. The increase in research and development expense during the three months ended June 30, 2026 was primarily attributable to an increase in manufacturing expense in connection with our subcutaneous development work, as well as other R&D manufacturing activities.
Stock-Based Compensation Expense (Selling, General and Administrative). Stock-based compensation expense (selling, general and administrative) related to equity incentive grants and liability-classified awards totaled $19.8 million for the three months ended June 30, 2026, as compared to $12.0 million during the comparable period ended June 30, 2025. The increase in stock-based compensation expense was primarily due to the mark-to-market impact on stock trading units, greater recognition of stock-based compensation expense for performance and market-based awards, and an increase in headcount during the three months ended June 30, 2026.
Other Selling, General and Administrative Expenses. Other selling, general and administrative expenses totaled $62.3 million for the three months ended June 30, 2026, as compared to $43.5 million during the comparable period ended June 30, 2025. The increase was primarily due to marketing and media spend, and personnel-related costs associated with the commercialization of BRIUMVI during the three months ended June 30, 2026.
Interest Expense. Interest expense totaled $16.6 million for the three months ended June 30, 2026, as compared to $6.7 million for the three months ended June 30, 2025. The increase is mainly due to increased interest expense pertaining to the First Amendment to the Financing Agreement with Blue Owl Capital during the three months ended June 30, 2026 (see Note 7 – Loan Payable for more information).
Other Income. Other income totaled $5.1 million for the three months ended June 30, 2026, as compared to $2.8 million during the comparable period ended June 30, 2025. The increase is mainly due to more income earned from investments during the three months ended June 30, 2026.
Income Tax Expense. Income tax expense totaled $2.5 million for the three months ended June 30, 2026, as compared to income tax expense of $2.7 million during the comparable period ended June 30, 2025. The decrease was primarily due to lower pre-tax income for the three months ended June 30, 2026, partially offset by a higher effective tax rate following the release of our deferred tax asset valuation allowance during the quarter ended September 30, 2025.
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The following table summarizes the results of operations for the six months ended June 30, 2026 and 2025:
Six months ended
June 30,
(in thousands) 2026 2025 Change
Product revenue, net $ 437,102 $ 258,498 $ 178,604
License, milestone, royalty and other revenue 8,151 3,506 4,645
Total Revenue $ 445,253 $ 262,004 $ 183,249
Costs and expenses:
Cost of revenue 74,704 34,479 40,225
Research and development:
Noncash compensation 12,945 7,649 5,296
Other research and development 130,788 70,495 60,293
Total research and development 143,733 78,144 65,589
General and administrative:
Noncash compensation 34,880 23,684 11,196
Other selling, general and administrative 135,467 82,232 53,235
Total general and administrative 170,347 105,916 64,431
Total costs and expenses 388,784 218,539 170,245
Interest expense 24,238 13,473 10,765
Loss on extinguishment of debt 9,153 — 9,153
Other income (7,519 ) (6,396 ) (1,123 )
Total other expense 25,872 7,077 18,795
Net income before taxes 30,597 36,388 (5,791 )
Income tax expense (3,039 ) (3,141 ) 102
Net income $ 27,558 $ 33,247 $ (5,689 )
Product Revenue, Net. Product revenue, net was approximately $437.1 million for the six months ended June 30, 2026, compared to $258.5 million for the six months ended June 30, 2025. Product revenue, net for both the six months ended June 30, 2026 and June 30, 2025 consisted of net product sales of BRIUMVI in the United States of $422.5 million and $258.5 million, respectively. Also included in product revenue, net for the six months ended June 30, 2026 is sales of BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, of $14.6 million. The increase in product revenue, net is a result of greater market penetration of BRIUMVI in the United States and from commercial product sales supplied to Neuraxpharm under the Commercialization Agreement.
License, Milestone, Royalty and Other Revenue. License, milestone, royalty and other revenue was $8.1 million for the six months ended June 30, 2026 and $3.5 million for the six months ended June 30, 2025. License, milestone, royalty and other revenue for the six months ended June 30, 2026 is comprised of $6.3 million of royalty revenue recognized under the Commercialization Agreement with Neuraxpharm and $1.8 million of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement (see Note 2 – Revenue for more information).
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Cost of Revenue. Cost of revenue for the six months ended June 30, 2026 was $74.7 million compared to approximately $34.5 million for the six months ended June 30, 2025. Cost of revenue for both periods consisted primarily of royalties owed to our licensing partner for BRIUMVI sales, as well as third-party manufacturing, distribution and overhead costs. The increase was primarily driven by growth in BRIUMVI U.S. sales volume and sales to our ex-U.S. licensing partner, Neuraxpharm, during the six months ended June 30, 2026. There were no sales to Neuraxpharm during the six months ended June 30, 2025. Gross margin on BRIUMVI U.S. net product revenue remained approximately 87% during the six months ended June 30, 2026. Total gross margin was approximately 83%, reflecting the impact of sales to Neuraxpharm and other revenue sources, which carry different margins than BRIUMVI U.S. net product revenue.
Stock-Based Compensation Expense (Research and Development). Stock-based compensation expense (research and development) related to equity incentive grants and liability-classified awards totaled $12.9 million for the six months ended June 30, 2026, as compared to $7.6 million during the comparable period ended June 30, 2025. The increase in stock-based compensation expense was primarily due to the mark to market impact on stock tracking units, greater recognition of stock-based compensation expense for performance and market-based awards, and an increase in headcount during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025.
Other Research and Development Expense. Other research and development expense was $130.8 million for the six months ended June 30, 2026, as compared to $70.5 million during the six months ended June 30, 2025. The increase in research and development expense during the six months ended June 30, 2026 was primarily attributable to an increase in manufacturing expense in connection with our subcutaneous development work, as well as other R&D manufacturing activities, and increased clinical trial related expenses pertaining to our clinical pipeline during the period ended June 30, 2026.
Stock-Based Compensation Expense (Selling, General and Administrative). Stock-based compensation expense (selling, general and administrative) related to equity incentive grants and liability-classified awards totaled $34.9 million for the six months ended June 30, 2026, as compared to $23.7 million during the comparable period ended June 30, 2025. The increase in stock-based compensation expense was primarily due to the mark-to-market impact on stock trading units, greater recognition of stock-based compensation expense for performance and market-based awards, and an increase in headcount during the six months ended June 30, 2026.
Other Selling, General and Administrative Expenses. Other selling, general and administrative expenses totaled $135.5 million for the six months ended June 30, 2026, as compared to $82.2 million during the comparable period ended June 30, 2025. The increase was primarily due to marketing and media spend, and personnel-related costs associated with the commercialization of BRIUMVI during the six months ended June 30, 2026.
Interest Expense. Interest expense totaled $24.2 million for the six months ended June 30, 2026, as compared to $13.5 million for the six months ended June 30, 2025. The increase is mainly due to increased interest expense pertaining to the First Amendment to the Financing Agreement with Blue Owl Capital during the six months ended June 30, 2026 (see Note 7 – Loan Payable for more information).
Loss on extinguishment of debt. Loss on extinguishment of debt totaled $9.2 million for the six months ended June 30, 2026 related to the write-off of unamortized deferred financing and debt discount costs, as well as prepayment fees associated with the Initial Term Loan with Blue Owl Capital, as compared to zero for the six months ended June 30, 2025 (see Note 7 – Loan Payable for more information).
Other Income. Other income totaled $7.5 million for the six months ended June 30, 2026, as compared to $6.4 million during the comparable period ended June 30, 2025. The increase is mainly due to more income earned from investments during the six months ended June 30, 2026.
Income Tax Expense. Income tax expense totaled $3.0 million for the six months ended June 30, 2026, as compared to income tax expense of $3.1 million during the comparable period ended June 30, 2025. The decrease was primarily due to lower pre-tax income for the six months ended June 30, 2026, partially offset by a higher effective tax rate following the release of our deferred tax asset valuation allowance during the quarter ended September 30, 2025.
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Material Cash Requirements and Contractual Obligations
Our material cash requirements primarily relate to the continued commercialization of BRIUMVI, including commercial operations, manufacturing and supply commitments, medical affairs activities, post-marketing requirements, and ongoing clinical development programs, as well as general and administrative expenses supporting our commercial-stage operations. Certain of these requirements arise from contractual commitments, while others are driven by our operating plan and the ordinary course of business.
We expect to fund these expenditures through existing cash, cash equivalents and investment securities, cash flows from BRIUMVI product sales, and, if needed, access to additional capital under the uncommitted portion of our term loan facility with Blue Owl Capital or other financing sources.
As of June 30, 2026, our contractual obligations consist primarily of purchase and supply commitments supporting the commercial and clinical manufacture of BRIUMVI. Certain of these agreements include non-cancelable provisions, minimum purchase requirements, or binding forecast commitments. We also maintain lease obligations for our office facilities in New York and North Carolina, which are expected to be funded through operating cash flows.
In accordance with our Financing Agreement with Blue Owl Capital, we are obligated to make interest and future principal payments.
We also enter into collaboration and license agreements that may require future milestone and royalty payments. Because these payments are contingent upon the achievement of specified events, they are not included in our contractual commitments but could become material in future periods.
Based on our current operating plan, financial resources, and projected results, we believe we have sufficient liquidity to fund operations and meet our material cash requirements for at least the next twelve months from the date of filing of this Quarterly Report on Form 10-Q. However, future capital requirements will depend on a number of factors, and additional financing may be required.
Discussion of Cash Flows
The following table summarizes our cash flows for the six months ended June 30, 2026 and 2025:
Six months ended
June 30,
(in thousands) 2026 2025
Net cash provided by (used in) operating activities $ 21,369 $ (21,279 )
Net cash used in investing activities $ (8,834 ) $ (16,926 )
Net cash provided by (used in) financing activities $ 390,914 $ (12,545 )
Net cash provided by operating activities for the six months ended June 30, 2026 was $21.4 million as compared to net cash used in operating activities of $21.3 million for the six months ended June 30, 2025, representing a $42.6 million improvement year over year.
The improvement was driven by higher non-cash adjustments to reconcile net income to net cash provided by operating activities and favorable working capital changes. Operating cash flow benefited from favorable working capital changes, including a decrease in other current assets as compared to an increase in the six months ended June 30, 2025, a $34.1 million improvement, a smaller increase in accounts receivable, a $6.4 million improvement, and a larger increase in accounts payable and accrued expenses, a $26.0 million improvement. These favorable impacts were partially offset by a larger increase in inventory purchases, a $37.4 million unfavorable year-over-year impact, and a decrease in income taxes payable, a $10.6 million unfavorable year-over-year impact.
Net cash used in investing activities for the six months ended June 30, 2026 was $8.8 million as compared to $16.9 million used in investing activities for the six months ended June 30, 2025. The improvement in net cash used in investing activities was primarily due to decreased investments in held-to-maturity securities during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, partially offset by decreased proceeds from maturity of held-to-maturity securities during the six months ended June 30, 2026.
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Net cash provided by financing activities for the six months ended June 30, 2026 was approximately $390.9 million as compared to net cash used in financing activities of $12.5 million for the six months ended June 30, 2025. Net cash provided by financing activities during the six months ended June 30, 2026 was mainly due to the proceeds from the 2026 Term Loan, net of financing costs paid, partially offset by the repurchase of stock under our share repurchase program. Net cash used in financing activities during the six months ended June 30, 2025 was mainly due to the repurchase of stock under our share repurchase program.
OFF-BALANCE SHEET ARRANGEMENTS
We have not entered into any transactions with unconsolidated entities whereby we have financial guarantees, subordinated retained interests, derivative instruments or other contingent arrangements that expose us to material continuing risks, contingent liabilities, or any other obligations under a variable interest in an unconsolidated entity that provides us with financing, liquidity, market risk or credit risk support.
CRITICAL ACCOUNTING POLICIES AND ACCOUNTING ESTIMATES
A critical accounting policy is one that is both important to the portrayal of our financial condition and results of operation and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. For a description of our significant accounting policies, refer to “Part II, Item 8. Financial Statements and Supplementary Data, Note 1 – Organization and Summary of Significant Accounting Policies” in our Annual Report on Form 10-K for the year ended December 31, 2025, and refer to Note 1 - Organization and Summary of Significant Accounting Policies in this Quarterly Report on Form 10-Q for significant accounting policies due to commercialization for revenue recognition, gross-to-net sales adjustments, accounts receivable, inventory, deferred tax asset valuation allowance, and cost of revenue. Of these policies, the following are considered critical to an understanding of our condensed consolidated financial statements as they require the application of the most difficult, subjective and complex judgments: revenue recognition and stock-based compensation expenses. Refer to Note 2 – Revenue and Note 6 – Stockholders’ Equity respectively, in this Quarterly Report on Form 10-Q for more information.