TG THERAPEUTICS, INC.
For the period ended Sep 30, 2026. Filed Nov 9, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 9, 2026
TGTX$63.38+5.9%Stored close · as of Nov 9, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-05.
0001437749-26-025955
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-09.
0001628280-26-072257
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 101 previous paragraphs and 144 current paragraphs.
48 unchanged; 44 reworded; 51 added; 7 removed; 2 previous and 1 current paragraphs rearranged.
Tables are not compared: 20 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (51)
Current report
Data Presentations at the 10th Joint ACTRIMS-ECTRIMS Meeting
Current report
In October 2026, we presented several data sets at MSToronto2026, the 10th Joint ACTRIMS-ECTRIMS Meeting including:
Current report
Azer-cel in Primary Progressive Multiple Sclerosis: We presented results from our Phase 1 study evaluating azer-cel in patients with primary progressive multiple sclerosis (PPMS). Initial data demonstrated an encouraging safety profile in 26 participants, with no dose-limiting or high-grade CAR T-associated toxicities observed. Despite prior disease progression, 89% of evaluable participants had stable or improved disability scores at Day 90 and 88% at Day 180, with longer-term follow-up ongoing.
Current report
Seven-Year BRIUMVI Data: We presented seven year follow-up data from the ULTIMATE I & II Phase 3 trials which supported the approval of BRIUMVI in relapsing MS. BRIUMVI demonstrated sustained efficacy with an annualized relapse rate (ARR) of 0.018 in the seventh year of treatment and 88.3% of continuously treated patients remaining free from 24-week confirmed disability progression. Patients receiving continuous BRIUMVI treatment experienced lower rates of disability progression than those who switched from teriflunomide, with a consistent long-term safety profile.
Current report
Phase 4 ENABLE Real-World Study: We presented updated data from 1,076 participants, 30% of whom switched from prior CD20 therapy, showed that 99.2% remained relapse-free during BRIUMVI treatment, with an ARR of 0.014. First-dose infusion-related reactions occurred in 18.8% of participants, and median subsequent infusion times of 63 minutes supported the one-hour infusion experience in clinical practice.
Current report
Development of BRIUMVI in MS
Current report
•In December 2020, we announced positive top-line results from the ULTIMATE I & II trials. Both studies met their primary endpoint of significantly reducing annualized relapse rate (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.
Current report
•On August 22, 2022, the full results from the ULTIMATE I & II trials were published in the New England Journal of Medicine.
Current report
•On December 28, 2022, we announced the FDA approved BRIUMVI for the treatment of RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Current report
•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.
Current report
•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.
Current report
•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.
Current report
•In October 2026, results from a five-year matching-adjusted indirect comparison (MAIC) evaluating long-term relapse activity and disability progression outcomes with BRIUMVI® (ublituximab-xiiy) compared with ocrelizumab and ofatumumab in patients with relapsing multiple sclerosis (RMS) were published online in Multiple Sclerosis and Related Disorders.
Current report
•In October 2026, we presented the full results from the Phase 3 ENHANCE trial as well as seven year follow up data from the ULTIMATE I & II Phase 3 trials and an update from the Phase 4 ENABLE real world study at the 2026 joint ACTRIMS-ECTRIMS meeting.
Current report
Development of BRIUMVI Outside of MS
Current report
•Consistent reductions from baseline were observed across all MG outcome measures over time following treatment with subcutaneous BRIUMVI
Current report
•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
Current report
•Overall, a mean 4.6 point improvement in MG-ADL was observed at Week 24
Current report
•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
Current report
U.S. Commercialization of BRIUMVI in MS and Market Dynamics
Current report
Development of Subcutaneous BRIUMVI (ublituximab)
Current report
•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.
Current report
•Subcutaneous BRIUMVI demonstrated mean bioavailability of greater than 60% relative to IV administration, with the lower bound of the 95% confidence interval exceeding 55%.
Current report
•PK modeling and simulation informed by the Phase 1 bioavailability data support the conclusion that:
Current report
◦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.
Current report
◦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.
Current report
◦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.
Current report
•Treatment with subcutaneous BRIUMVI resulted in B-cell depletion consistent with IV BRIUMVI, supporting the biological activity of the subcutaneous formulation.
Current report
•Subcutaneous administration was generally well tolerated, with treatment-emergent adverse events (TEAEs) consistent with the known safety profile of IV BRIUMVI.
Current report
•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.
Current report
•No serious injection-site reactions and no new safety signals were observed.
Current report
In October 2026, the full results from the Phase 1 clinical trial evaluating a high-concentration (400 mg/2 mL) subcutaneous ublituximab as compared to IV BRIUMVI in participants with RMS were presented at the 2026 joint ACTRIMS-ECTRIMS meeting.
Current report
In October 2026, we presented the initial results from our Phase 1 study evaluating azer-cel in patients with PPMS at the 2026 joint ACTRIMS-ECTRIMS meeting. Initial data demonstrated an encouraging safety profile in 26 participants, with no dose-limiting or high-grade CAR T-associated toxicities observed. Despite prior disease progression, 89% of evaluable participants had stable or improved disability scores at Day 90 and 88% at Day 180, with longer-term follow-up ongoing.
Current report
•the timing and success of the ongoing commercialization of BRIUMVI and any other products for which we receive regulatory approval;
Current report
•the costs and timing of clinical and commercial manufacturing supply arrangements for each product and product candidate;
Current report
•the costs of expanding our sales, distribution, and other commercialization capabilities;
Current report
•the costs and timing of regulatory approvals;
Current report
•the progress of our clinical trials, including expenses to support the trials and milestone payments that may become payable under our license agreements;
Current report
•our ability to establish and maintain strategic collaborations, including licensing and other arrangements;
Current report
•the costs involved in enforcing or defending patent claims or other intellectual property rights; and
Showing the first 40 of 51 passages. Open the source sections for the rest.
Removed paragraphs (7)
Previous report
Subcutaneous BRIUMVI in RMS
Previous report
BRIUMVI in Myasthenia Gravis
Previous report
BRIUMVI in Schizophrenia
Previous report
Development of BRIUMVI
Previous report
U.S. Commercialization of BRIUMVI and Market Dynamics
Previous report
Subcutaneous Ublituximab Overview
Previous report
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.
Reworded paragraphs (44)
Previous wording
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.
Current wording
Subcutaneous BRIUMVI in RMS: We presented the previously announced positive pharmacokinetic (PK), pharmacodynamic (PD), safety, and tolerability data from the Phase 1 clinical trial evaluating a 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.
Previous wording
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.
Current wording
•In May 2026, we announced the Phase 3 ENHANCE trial, a randomized, double-blind study evaluating a consolidated single infusion regimen for initiation of BRIUMVI in adults with RMS, 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.
Previous wording
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:
Current wording
•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 and the initiation of a Phase 2 clinical trial evaluating BRIUMVI as a maintenance therapy following induction with efgartigimod in adult patients with MG. In the Phase 1, 11 patients were treated across cohorts that demonstrated subcutaneous BRIUMVI exposure at least equivalent to the approved IV BRIUMVI regimen. Key data highlights included:
Previous wording
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.
Current wording
BRIUMVI (ublituximab-xiiy), an anti-CD20 monoclonal antibody indicated for the treatment of adults with RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, was approved by the 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 payor coverage, and supporting patient access within a competitive RMS treatment landscape.
Previous wording
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.
Current wording
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, payor coverage and utilization management requirements, competitive contracting, site-of-care logistics, and evolving treatment guidelines.
Previous wording
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.
Current wording
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, payor 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 payors.
Previous wording
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.
Current wording
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 payor 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 payor contracting strategies evolve, the magnitude and variability of these adjustments may change.
Previous wording
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.
Current wording
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 European Union (EU) member states, Iceland, Norway and Liechtenstein.
Previous wording
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.
Current wording
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 subject to previously existing partnerships.
Previous wording
BRIUMVI is now approved in the European Union, the United Kingdom, Switzerland, Australia, Kuwait, the United Arab Emirates, Israel, Saudi Arabia and Brazil.
Current wording
BRIUMVI is now approved in the EU, the United Kingdom, Switzerland, Australia, Kuwait, the United Arab Emirates, Israel, Saudi Arabia, Iceland and Brazil.
Previous wording
In January 2025, we announced the first patients with myasthenia gravis (MG) had been enrolled in a clinical trial evaluating subcutaneous ublituximab.
Current wording
In January 2025, we announced the first patients with MG had been enrolled in a clinical trial evaluating subcutaneous ublituximab.
Previous wording
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.
Current wording
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, a significant complication associated with other donor-derived, cell-based therapies.
Previous wording
For more information, please refer to our Annual Report on Form 10-K for the quarter and year ended December 31, 2025.
Current wording
For more information, please refer to our Annual Report on Form 10-K for the year ended December 31, 2025.
Previous wording
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.
Current wording
For the nine months ended September 30, 2026, we generated revenue of $705.2 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.
Previous wording
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.
Current wording
As of September 30, 2026, our accumulated deficit was approximately $1.0 billion, and we had $556.7 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.
Previous wording
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.
Current wording
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 three months ended March 31, 2025 are not included in the cost of product revenue during those periods.
Previous wording
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.
Current wording
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, the timing of overhead allocation and tariffs.
Previous wording
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.
Current wording
Product Revenue, Net. Product revenue, net was approximately $240.0 million for the three months ended September 30, 2026, compared to $159.3 million for the three months ended September 30, 2025. Product revenue, net for both the three months ended September 30, 2026 and 2025 consisted of net product sales of BRIUMVI in the United States of $232.6 million and $152.9 million, respectively. Also included in product revenue, net for the three months ended September 30, 2026 and 2025 is sales of BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, of $7.4 million and $6.4 million, respectively. 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.
Previous wording
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).
Current wording
License, Milestone, Royalty and Other Revenue. License, milestone, royalty and other revenue was $19.9 million for the three months ended September 30, 2026 and $2.4 million for the three months ended September 30, 2025. License, milestone, royalty and other revenue for the three months ended September 30, 2026 is comprised of $4.1 million of royalty revenue recognized under the Commercialization Agreement with Neuraxpharm and $15.8 million of license, milestone, and other revenue, including $10.0 million related to a sales milestone achieved during the period, $5.0 million in license revenue, and $0.8 million for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement (see Note 2 – Revenue for more information).
Previous wording
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.
Current wording
Cost of Revenue. Cost of revenue for the three months ended September 30, 2026 was $42.1 million compared to approximately $28.1 million for the three months ended September 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 September 30, 2026. Gross margin on BRIUMVI U.S. net product revenue remained approximately 87% during the three months ended September 30, 2026. Total gross margin was approximately 84%, reflecting the impact of sales to Neuraxpharm and other revenue sources, which carry different margins than BRIUMVI U.S. net product revenue.
Previous wording
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.
Current wording
Stock-Based Compensation Expense (Research and Development). Stock-based compensation expense (research and development) related to equity incentive grants and liability-classified awards totaled $7.6 million for the three months ended September 30, 2026, as compared to $5.3 million during the comparable period ended September 30, 2025. The increase in stock-based compensation expense for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025, was primarily due to the mark-to-market impact on stock tracking units and an increase in headcount.
Previous wording
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.
Current wording
Other Research and Development Expense. Other research and development expense was $43.7 million for the three months ended September 30, 2026, as compared to $35.5 million during the three months ended September 30, 2025. The increase in research and development expense during the three months ended September 30, 2026 was primarily attributable to an increase in clinical trial related expenses pertaining to our clinical pipeline during the period ended September 30, 2026.
Previous wording
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.
Current wording
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 $17.2 million for the three months ended September 30, 2026, as compared to $12.4 million during the comparable period ended September 30, 2025. The increase in stock-based compensation expense was primarily due to the mark-to-market impact on stock tracking units, and greater recognition of stock-based compensation expense for market-based awards during the three months ended September 30, 2026.
Previous wording
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.
Current wording
Other Selling, General and Administrative Expenses. Other selling, general and administrative expenses totaled $63.5 million for the three months ended September 30, 2026, as compared to $51.0 million during the comparable period ended September 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 September 30, 2026.
Previous wording
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).
Current wording
Interest Expense. Interest expense totaled $15.8 million for the three months ended September 30, 2026, as compared to $6.7 million for the three months ended September 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 September 30, 2026 (see Note 7 – Loan Payable for more information).
Previous wording
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.
Current wording
Other Income. Other income totaled $3.8 million for the three months ended September 30, 2026, as compared to $3.3 million during the comparable period ended September 30, 2025. The increase is mainly due to more income earned from investments during the three months ended September 30, 2026.
Previous wording
***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.
Current wording
Income Tax (Expense) Benefit. Income tax expense totaled $18.4 million for the three months ended September 30, 2026, as compared to income tax benefit of $365.0 million during the comparable period ended September 30, 2025. The decrease was primarily due to the discrete release of our deferred tax asset valuation allowance during the quarter ended September 30, 2025.
Previous wording
The following table summarizes the results of operations for the six months ended June 30, 2026 and 2025:
Current wording
The following table summarizes the results of operations for the nine months ended September 30, 2026 and 2025:
Previous wording
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.
Current wording
Product Revenue, Net. Product revenue, net was approximately $677.1 million for the nine months ended September 30, 2026, compared to $417.8 million for the nine months ended September 30, 2025. Product revenue, net for both the nine months ended September 30, 2026 and September 30, 2025 consisted of net product sales of BRIUMVI in the United States of $655.1 million and $411.4 million, respectively. Also included in product revenue, net for the nine months ended September 30, 2026 and 2025 is sales of BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, of $22.0 million and $6.4 million, respectively. 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.
Previous wording
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).
Current wording
License, Milestone, Royalty and Other Revenue. License, milestone, royalty and other revenue was $28.0 million for the nine months ended September 30, 2026 and $5.9 million for the nine months ended September 30, 2025. License, milestone, royalty and other revenue for the nine months ended September 30, 2026 is comprised of $10.4 million of royalty revenue recognized under the Commercialization Agreement with Neuraxpharm, and $17.6 million of license, milestone, and other revenue, including $10.0 million related to a sales milestone achieved during the period, $5.0 million in license revenue, and $2.6 million for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement (see Note 2 – Revenue for more information).
Previous wording
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.
Current wording
Cost of Revenue. Cost of revenue for the nine months ended September 30, 2026 was $116.8 million compared to approximately $62.6 million for the nine months ended September 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 nine months ended September 30, 2026. Gross margin on BRIUMVI U.S. net product revenue remained approximately 87% during the nine months ended September 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.
Previous wording
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.
Current wording
Stock-Based Compensation Expense (Research and Development). Stock-based compensation expense (research and development) related to equity incentive grants and liability-classified awards totaled $20.5 million for the nine months ended September 30, 2026, as compared to $13.0 million during the comparable period ended September 30, 2025. The increase in stock-based compensation expense was primarily due to the mark to market impact on stock tracking units, and an increase in headcount during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025.
Previous wording
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.
Current wording
Other Research and Development Expense. Other research and development expense was $174.5 million for the nine months ended September 30, 2026, as compared to $106.0 million during the nine months ended September 30, 2025. The increase in research and development expense during the nine months ended September 30, 2026 was primarily attributable to an increase in manufacturing expense in connection with our subcutaneous development work, and increased clinical trial related expenses pertaining to our clinical pipeline during the period ended September 30, 2026.
Previous wording
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.
Current wording
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 $52.0 million for the nine months ended September 30, 2026, as compared to $36.0 million during the comparable period ended September 30, 2025. The increase in stock-based compensation expense was primarily due to the mark-to-market impact on stock tracking units, and greater recognition of stock-based compensation expense for market-based awards during the nine months ended September 30, 2026.
Previous wording
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.
Current wording
Other Selling, General and Administrative Expenses. Other selling, general and administrative expenses totaled $199.0 million for the nine months ended September 30, 2026, as compared to $133.3 million during the comparable period ended September 30, 2025. The increase was primarily due to marketing and media spend, and personnel-related costs associated with the commercialization of BRIUMVI during the nine months ended September 30, 2026.
Previous wording
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).
Current wording
Interest Expense. Interest expense totaled $40.1 million for the nine months ended September 30, 2026, as compared to $20.2 million for the nine months ended September 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 nine months ended September 30, 2026 (see Note 7 – Loan Payable for more information).
Previous wording
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).
Current wording
Loss on extinguishment of debt. Loss on extinguishment of debt totaled $9.2 million for the nine months ended September 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 nine months ended September 30, 2025 (see Note 7 – Loan Payable for more information).
Previous wording
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.
Current wording
Other Income. Other income totaled $11.3 million for the nine months ended September 30, 2026, as compared to $9.7 million during the comparable period ended September 30, 2025. The increase is mainly due to more income earned from investments during the nine months ended September 30, 2026.
Previous wording
***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.
Current wording
Income Tax (Expense) Benefit. Income tax expense totaled $21.4 million for the nine months ended September 30, 2026, as compared to income tax benefit of $361.8 million during the comparable period ended September 30, 2025. The decrease was primarily due to the discrete release of our deferred tax asset valuation allowance during the quarter ended September 30, 2025.
Previous wording
The following table summarizes our cash flows for the six months ended June 30, 2026 and 2025:
Current wording
The following table summarizes our cash flows for the nine months ended September 30, 2026 and 2025:
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Current report — wording carried from elsewhere
ENHANCE Phase 3 Trial in RMS: We presented 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 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. Infusion-related reactions were comparable between regimens, with no Grade 3 or higher reactions observed, supporting the potential for a simplified treatment initiation schedule.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
ENHANCE Phase 3 Trial in RMS
Previous report — wording carried elsewhere
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.