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TG THERAPEUTICS, INC.

For the period ended Sep 30, 2025. Filed Nov 5, 2025.

View on SEC.gov

About this filing

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, 2025 · Filed Nov 5, 2025

TGTX$59.83+3.2%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-08.

0001437749-25-025745

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-05.

0001437749-25-033363

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 55 previous paragraphs and 61 current paragraphs.

22 unchanged; 30 reworded; 9 added; 2 removed; 1 previous and 0 current paragraphs rearranged.

Tables are not compared: 5 previous and 5 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 (9)

Current report

In September 2025, we completed our previously authorized $100 million share repurchase program, which was initially announced in August 2024 (the Prior Share Repurchase Program). Under the Prior Share Repurchase Program, we repurchased a total of 3,502,334 shares of our common stock at an average price of $28.55 per share. In September 2025, the Board authorized and approved a new share repurchase program (the 2025 Share Repurchase Program) for up to $100 million of the currently outstanding shares of our common stock. There were no repurchases under the 2025 Share Repurchase Program for the three and nine months ended September 30, 2025.

Current report

BRIUMVI is now approved in the European Union, the United Kingdom, Switzerland, Australia, Kuwait and the United Arab Emirates.

Current report

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 will be 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 non inferior exposure of subcutaneous ublituximab compared to IV BRIUMVI with respect to area under the curve (AUC) at week 24.

Current report

Interest Expense. Interest expense totaled $6.7 million for the three months ended September 30, 2025, as compared to $10.8 million for the three months ended September 30, 2024. The decrease is mainly due to $4.6 million of debt extinguishment costs in connection with the termination of our prior loan agreement with Hercules during the three months ended September 30, 2024.

Current report

***Income Tax Benefit (Expense).***Income tax benefit totaled $365.0 million for the three months ended September 30, 2025, as compared to income tax expense of ($0.4) million during the comparable period ended September 30, 2024. The increase in income tax benefit is driven by the release of our deferred tax asset valuation allowance during the three months ended September 30, 2025.

Current report

***Income Tax Benefit (Expense).***Income tax benefit totaled $361.8 million for the nine months ended September 30, 2025, as compared to income tax expense of ($0.1) million during the comparable period ended September 30, 2024. The increase in income tax benefit is driven by the release of our deferred tax asset valuation allowance during the nine months ended September 30, 2025.
Removed paragraphs (2)

Previous report

In August 2025 we announced the Phase 3 pivotal program will evaluate two dosing schedules, every other month and quarterly, compared to IV BRIUMVI in patients with relapsing forms of MS. The primary endpoint is to demonstrate non-inferior exposure between subcutaneous dosing and our approved IV dosing, and patient enrollment is set to commence in the coming weeks.
Reworded paragraphs (30)

Previous wording

TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the FDA for BRIUMVI (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults, as well as approval by the European Commission (EC), the Medicines and Healthcare Products Regulatory Agency (MHRA), Swissmedic, and Australia’s Therapeutic Goods Administration (TGA) 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.

Current wording

TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline of investigational medicines, TG has received approval from the FDA for BRIUMVI (ublituximab-xiiy) to treat adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults, as well as approval from several regulatory authorities outside of the U.S. 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.

Previous wording

In June 2023, we announced that the EC granted approval of BRIUMVI for the treatment of 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 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 (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 the Company 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 of which we previously partnered.

Previous wording

In February 2024, we announced the commercial launch of BRIUMVI in the EU by Neuraxpharm, with BRIUMVI made available for commercial sale in Germany, and is now commercially available in several other countries in the European Union, and United Kingdom. BRIUMVI is now also approved in Switzerland and Australia.

Current wording

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

Previous wording

In August 2024, we announced the initiation of a Phase 1 clinical trial evaluating subcutaneous BRIUMVI (ublituximab) in patients with RMS.

Current wording

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.

Previous wording

Azer-cel is an allogeneic (off-the-shelf) CD19-directed CAR T cell therapy under development by the Company 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 has been dosed with azer-cel in a Phase 1 trial.

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 (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 has been dosed with azer-cel in a Phase 1 trial.

Previous wording

Product Revenue, Net*.*Product revenue, net was approximately $138.8 million for the three months ended June 30, 2025, compared to $72.6 million for the three months ended June 30, 2024. Product revenue, net for both the three months ended June 30, 2025 and June 30, 2024 consisted of net product sales of BRIUMVI in the United States. The increase in product revenue, net is a result of greater market penetration.

Current wording

Product Revenue, Net*.*Product revenue, net was approximately $159.3 million for the three months ended September 30, 2025, compared to $83.3 million for the three months ended September 30, 2024. Product revenue, net for both the three months ended September 30, 2025 and September 30, 2024 consisted of net product sales of BRIUMVI in the United States of $152.9 million and $83.3 million, respectively. Also included in product revenue, net for the three months ended September 30, 2025 are sales of BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, of $6.4 million. The increase in product revenue, net is a result of greater market penetration.

Previous wording

License, Milestone, Royalty and Other Revenue. License, milestone, royalty and other revenue was $2.3 million for the three months ended June 30, 2025 and $0.9 million for the three months ended June 30, 2024. License, milestone, royalty and other revenue for the three months ended June 30, 2025 is comprised of $1.2 million of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement and $1.1 million of royalty revenue recognized under the Commercialization Agreement with Neuraxpharm (see Note 2 - Revenue for more information). License, milestone, royalty and other revenue for the three months ended June 30, 2024 is primarily comprised 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 $2.4 million for the three months ended September 30, 2025 and $0.6 million for the three months ended September 30, 2024. License, milestone, royalty and other revenue for the three months ended September 30, 2025 is comprised of $0.9 million of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement and $1.5 million of royalty revenue recognized under the Commercialization Agreement with Neuraxpharm (see Note 2 - Revenue for more information). License, milestone, royalty and other revenue for the three months ended September 30, 2024 is primarily comprised 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).

Previous wording

Cost of Revenue. Cost of revenue for the three months ended June 30, 2025 was $18.9 million compared to approximately $8.3 million for the three months ended June 30, 2024. Cost of revenue for both the three months ended June 30, 2025 and June 30, 2024 consists primarily of royalties owed to our licensing partner for BRIUMVI sales, third-party manufacturing, distribution and overhead costs. A portion of the manufacturing costs of BRIUMVI sold during the quarter ending June 30, 2024 was expensed as research and development prior to the FDA approval of BRIUMVI and therefore it is not reflected in the cost of revenue. We depleted these inventories during the quarter ending March 31, 2025; therefore, the cost of revenue for BRIUMVI increased modestly in relation to product revenues during the three months ended June 30, 2025.

Current wording

Cost of Revenue. Cost of revenue for the three months ended September 30, 2025 was $28.1 million compared to approximately $9.3 million for the three months ended September 30, 2024. Cost of revenue for both the three months ended September 30, 2025 and September 30, 2024 consists primarily of royalties owed to our licensing partner for BRIUMVI sales, third-party manufacturing, distribution and overhead costs. A portion of the manufacturing costs of BRIUMVI sold during the quarter ending September 30, 2024 was expensed as research and development prior to the FDA approval of BRIUMVI and therefore it is not reflected in the cost of revenue. We depleted these inventories during the quarter ending March 31, 2025.

Previous wording

Noncash Compensation Expense (Research and Development). Noncash compensation expense (research and development) related to equity incentive grants totaled $4.3 million for the three months ended June 30, 2025, as compared to $2.5 million during the comparable period ended June 30, 2024. The modest increase in noncash compensation expense was primarily due to an increase in headcount and stock price at which equity awards were granted during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024.

Current wording

Noncash Compensation Expense (Research and Development). Noncash compensation expense (research and development) related to equity incentive grants totaled $5.3 million for the three months ended September 30, 2025, as compared to $3.0 million during the comparable period ended September 30, 2024. The increase in noncash compensation expense was primarily due to greater recognition of noncash compensation expense for performance-based awards and increased stock price at which equity awards were granted during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024.

Previous wording

Other Research and Development Expense*.*Other research and development expense was $70.5 million for the six months ended June 30, 2025, as compared to $45.3 million during the six months ended June 30, 2024. The increase in research and development expense during the six months ended June 30, 2025 was primarily due to an increase in manufacturing expense in connection with our ublituximab subcutaneous development work during the period ended June 30, 2025.

Current wording

Other Research and Development Expense*.*Other research and development expense was $35.5 million for the three months ended September 30, 2025, as compared to $17.1 million during the three months ended September 30, 2024. The increase in research and development expense during the three months ended September 30, 2025 was primarily due to an increase in manufacturing expense, including manufacturing and development costs incurred in connection with our subcutaneous ublituximab development work during the period ended September 30, 2025, as well as increased clinical trial related expenses pertaining to our clinical pipeline, and increased personnel costs, partially offset by a one-time milestone payment made in 2024.

Previous wording

Noncash Compensation Expense (Selling, General and Administrative).*** ***Noncash compensation expense (selling, general and administrative) related to equity incentive grants totaled $12.0 million for the three months ended June 30, 2025, as compared to $7.0 million during the comparable period ended June 30, 2024. The increase in noncash compensation expense was primarily due to greater recognition of noncash compensation expense for market-based awards during the three months ended June 30, 2025.

Current wording

Noncash Compensation Expense (Selling, General and Administrative).*** ***Noncash compensation expense (selling, general and administrative) related to equity incentive grants totaled $12.4 million for the three months ended September 30, 2025, as compared to $8.7 million during the comparable period ended September 30, 2024. The increase in noncash compensation expense was primarily due to greater recognition of noncash compensation expense for performance and market-based awards and an increase in headcount and stock price at which equity awards were granted during the three months ended September 30, 2025.

Previous wording

Other Selling, General and Administrative Expenses. Other selling, general and administrative expenses totaled $43.5 million for the three months ended June 30, 2025, as compared to $31.8 million during the comparable period ended June 30, 2024. The increase was primarily due to other selling, general and administrative costs, including marketing personnel and external costs associated with the commercialization of BRIUMVI during the three months ended June 30, 2025.

Current wording

Other Selling, General and Administrative Expenses. Other selling, general and administrative expenses totaled $51.0 million for the three months ended September 30, 2025, as compared to $33.2 million during the comparable period ended September 30, 2024. The increase was primarily due to other selling, general and administrative costs, including marketing personnel and external costs associated with the commercialization of BRIUMVI during the three months ended September 30, 2025.

Previous wording

Other Income.*** ***Other income totaled $2.8 million for the three months ended June 30, 2025, as compared to $1.7 million during the comparable period ended June 30, 2024. The increase is mainly due to higher interest income received from our investments during the period.

Current wording

Other Income.*** ***Other income totaled $3.3 million for the three months ended September 30, 2025, as compared to $2.7 million during the comparable period ended September 30, 2024. The increase is mainly due to higher interest income received from our investments during the period.

Previous wording

The following table summarizes the results of operations for the six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes the results of operations for the nine months ended September 30, 2025 and 2024:

Previous wording

Product Revenue, Net*.*Product revenue, net was approximately $258.5 million for the six months ended June 30, 2025, compared to $123.1 million for the six months ended June 30, 2024. Product revenue, net for both the six months ended June 30, 2025 and June 30, 2024 consisted of net product sales of BRIUMVI in the United States. The increase in product revenue, net is a result of greater market penetration.

Current wording

Product Revenue, Net*.*Product revenue, net was approximately $417.8 million for the nine months ended September 30, 2025, compared to $206.4 million for the nine months ended September 30, 2024. Product revenue, net for both the nine months ended September 30, 2025 and September 30, 2024 consisted of net product sales of BRIUMVI in the United States of $411.4 million and $206.4 million, respectively. Also included in product revenue, net for the nine months ended September 30, 2025 are sales of BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, of $6.4 million. The increase in product revenue, net is a result of greater market penetration.

Previous wording

License, Milestone, Royalty and Other Revenue. License, milestone, royalty and other revenue was $3.5 million for the six months ended June 30, 2025 and $13.9 million for the six months ended June 30, 2024. License, milestone, royalty and other revenue for the six months ended June 30, 2025 is primarily comprised $1.8 million of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement and $1.7 million of royalty revenue recognized under the Commercialization Agreement with Neuraxpharm (see Note 2 - Revenue for more information). License, milestone, royalty and other revenue for the six months ended June 30, 2024 is predominantly comprised of recognition of the one-time $12.5 million milestone payment under the Commercialization Agreement for the first key market commercial launch of BRIUMVI in the EU.

Current wording

License, Milestone, Royalty and Other Revenue. License, milestone, royalty and other revenue was $5.9 million for the nine months ended September 30, 2025 and $14.4 million for the nine months ended September 30, 2024. License, milestone, royalty and other revenue for the nine months ended September 30, 2025 is primarily comprised $2.7 million of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement and $3.2 million of royalty revenue recognized under the Commercialization Agreement with Neuraxpharm (see Note 2 - Revenue for more information). License, milestone, royalty and other revenue for the nine months ended September 30, 2024 is predominantly comprised of recognition of the one-time $12.5 million milestone payment under the Commercialization Agreement for the first key market commercial launch of BRIUMVI in the EU.

Previous wording

Cost of Revenue. Cost of revenue for the six months ended June 30, 2025 was $34.5 million compared to approximately $13.7 million for the six months ended June 30, 2024. Cost of revenue for both the six months ended June 30, 2025 and June 30, 2024 consists primarily of royalties owed to our licensing partner for BRIUMVI sales, third-party manufacturing, distribution and overhead costs. A portion of the manufacturing costs of BRIUMVI sold through the middle of the quarter ending March 31, 2025 was expensed as research and development prior to the FDA approval of BRIUMVI and therefore it is not reflected in the cost of revenue. We depleted these inventories during the quarter ending March 31, 2025; therefore, the cost of revenue for BRIUMVI increased modestly in relation to product revenues during the six months ended June 30, 2025.

Current wording

Cost of Revenue. Cost of revenue for the nine months ended September 30, 2025 was $62.6 million compared to approximately $23.1 million for the nine months ended September 30, 2024. Cost of revenue for both the nine months ended September 30, 2025 and September 30, 2024 consists primarily of royalties owed to our licensing partner for BRIUMVI sales, third-party manufacturing, distribution and overhead costs. A portion of the manufacturing costs of BRIUMVI sold through the middle of the quarter ending March 31, 2025 was expensed as research and development prior to the FDA approval of BRIUMVI and therefore it is not reflected in the cost of revenue. We depleted these inventories during the quarter ending March 31, 2025.

Previous wording

Noncash Compensation Expense (Research and Development). Noncash compensation expense (research and development) related to equity incentive grants totaled $7.6 million for the six months ended June 30, 2025, as compared to $5.0 million during the comparable period ended June 30, 2024. The modest increase in noncash compensation expense was primarily due to an increase in headcount and stock price at which equity awards were granted during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024.

Current wording

Noncash Compensation Expense (Research and Development). Noncash compensation expense (research and development) related to equity incentive grants totaled $13.0 million for the nine months ended September 30, 2025, as compared to $8.0 million during the comparable period ended September 30, 2024. The increase in noncash compensation expense was primarily due to greater recognition of noncash compensation expense for performance-based awards and increased stock price at which equity awards were granted during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024.

Previous wording

Other Research and Development Expense*.*Other research and development expense was $27.5 million for the three months ended June 30, 2025, as compared to $15.0 million during the three months ended June 30, 2024. The increase in research and development expense during the three months ended June 30, 2025 was primarily due to an increase in manufacturing expense in connection with our ublituximab subcutaneous development work during the period ended June 30, 2025, as well as increased clinical trial related expenses pertaining to our clinical pipeline, and increased personnel costs.

Current wording

Other Research and Development Expense*.*Other research and development expense was $106.0 million for the nine months ended September 30, 2025, as compared to $62.4 million during the nine months ended September 30, 2024. The increase in research and development expense during the nine months ended September 30, 2025 was primarily due to an increase in manufacturing expense, including manufacturing and development costs incurred in connection with our subcutaneous ublituximab development work during the period ended September 30, 2025, as well as increased clinical trial related expenses pertaining to our clinical pipeline, and increased personnel costs.

Previous wording

Noncash Compensation Expense (Selling, General and Administrative).*** ***Noncash compensation expense (selling, general and administrative) related to equity incentive grants totaled $23.7 million for the six months ended June 30, 2025, as compared to $13.8 million during the comparable period ended June 30, 2024. The increase in noncash compensation expense was primarily due to greater recognition of noncash compensation expense for market-based awards during the six months ended June 30, 2025.

Current wording

Noncash Compensation Expense (Selling, General and Administrative).*** ***Noncash compensation expense (selling, general and administrative) related to equity incentive grants totaled $36.0 million for the nine months ended September 30, 2025, as compared to $22.6 million during the comparable period ended September 30, 2024. The increase in noncash compensation expense was primarily due to greater recognition of noncash compensation expense for performance and market-based awards and an increase in headcount and stock price at which equity awards were granted during the nine months ended September 30, 2025.

Previous wording

Other Selling, General and Administrative Expenses.*** ***Other selling, general and administrative expenses totaled $82.2 million for the six months ended June 30, 2025, as compared to $59.5 million during the comparable period ended June 30, 2024. The increase was primarily due to other selling, general and administrative costs, including marketing personnel and external costs associated with the commercialization of BRIUMVI during the six months ended June 30, 2025.

Current wording

Other Selling, General and Administrative Expenses.*** ***Other selling, general and administrative expenses totaled $133.3 million for the nine months ended September 30, 2025, as compared to $92.7 million during the comparable period ended September 30, 2024. The increase was primarily due to other selling, general and administrative costs, including marketing personnel and external costs associated with the commercialization of BRIUMVI during the nine months ended September 30, 2025.

Previous wording

Interest Expense. Interest expense totaled $6.7 million for the three months ended June 30, 2025, as compared to $4.0 million for the three months ended June 30, 2025. The increase is mainly due to increased interest expense pertaining to the Initial Term Loan with Blue Owl during the period ended June 30, 2025 (see Note 7 - Loan Payable for more information).

Current wording

Interest Expense.*** ***Interest expense totaled $20.2 million for the nine months ended September 30, 2025, as compared to $17.0 million for the nine months ended September 30, 2024. The increase is mainly due to increased interest expense pertaining to the Initial Term Loan with Blue Owl during the period ended September 30, 2025 (see Note 7 - Loan Payable for more information).

Previous wording

Other Income.*** ***Other income totaled $6.4 million for the six months ended June 30, 2025, as compared to $2.6 million during the comparable period ended June 30, 2024. The increase is mainly due to higher interest income received from our investments during the period.

Current wording

Other Income.*** ***Other income totaled $9.7 million for the nine months ended September 30, 2025, as compared to $5.1 million during the comparable period ended September 30, 2024. The increase is mainly due to higher interest income received from our investments during the period.

Previous wording

While we recently began generating net income, we have incurred significant operating losses since our inception. BRIUMVI first became commercially available in the United States in January of 2023, and ex-US through our partner Neuraxpharm, in February 2024. Even with the commercialization of BRIUMVI and the possible future commercialization of our other drug candidates, we may not realize continued profitability. During the six months ended June 30, 2025, we generated $262.0 million in revenue. Historically, substantially all our operating losses have resulted from costs incurred in connection with our research and development programs and from selling, general and administrative costs associated with our operations, including our commercialization activities to date. Our future operating results, profitability and other financial results may fluctuate from period to period, and we will need to generate significant revenues to maintain profitability and/or positive cash flow on a sustained basis. As of June 30, 2025, we have an accumulated deficit of approximately $1.5 billion.

Current wording

Although we have recently achieved profitability, we have incurred substantial operating losses since our inception. BRIUMVI was first commercially launched in the United States in January of 2023, and ex-US through our partner Neuraxpharm in February 2024. Despite the commercialization of BRIUMVI and the potential future commercialization of our other drug candidates, there can be no assurance that we will maintain profitability on an ongoing basis. For the nine months ended September 30, 2025, we generated revenue of $423.7 million. Historically, our operating losses have been driven primarily by expenses related to research and development programs and from selling, general and administrative costs associated with our operations and commercialization activities to date. Our future operating results and cash flows may fluctuate significantly from period to period, and we will need to generate substantial revenues to sustain profitability and positive cash flow over the long term. As of September 30, 2025, our accumulated deficit was approximately $1.1 billion.

Previous wording

As of June 30, 2025, we had $278.9 million in cash and cash equivalents, and investment securities. We anticipate that our cash, cash equivalents, and investment securities, combined with projected future revenues will provide sufficient liquidity for more than a twelve-month period from the date of filing this Quarterly Report on Form 10-Q. The actual amount of cash that we will need to operate is subject to many factors, including, but not limited to, our commercialization efforts for BRIUMVI and the timing, design and conduct of clinical trials for our drug candidates as well as the costs associated with licensing or otherwise acquiring new product candidates. We may be dependent upon significant future financing to provide the cash necessary to execute our ongoing and future operations.

Current wording

As of September 30, 2025, we had $178.3 million in cash and cash equivalents, and investment securities. We anticipate that our cash, cash equivalents, and investment securities, combined with projected future revenues will be sufficient to meet our liquidity needs for more than twelve-months from the date of filing 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, timing of collection of receivables from our customers on extended payment terms, the timing and design of clinical trials for our product candidates, and costs associated with licensing or acquiring new product candidates. We may require significant additional financing in the future to support our ongoing and planned operations.

Previous wording

The following table summarizes our cash flows for the six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes our cash flows for the nine months ended September 30, 2025 and 2024:

Previous wording

Cash used in operating activities for the six months ended June 30, 2025 was $21.3 million as compared to cash used in operating activities of $2.7 million for the six months ended June 30, 2024. The increase in net cash used in operating activities was due to an increase in accounts receivable during the six months ended June 30, 2025 and inventory purchases during the same period, partially offset by increase in accounts payable.

Current wording

Cash used in operating activities for the nine months ended September 30, 2025 was $44.4 million as compared to cash used in operating activities of $14.9 million for the nine months ended September 30, 2024. The increase in net cash used in operating activities was primarily due to an increase in accounts receivable during the nine months ended September 30, 2025, partially offset by an increase in accounts payable.

Previous wording

Net cash used in investing activities for the six months ended June 30, 2025 was $16.9 million as compared to $7.5 million used in investing activities for the six months ended June 30, 2024. The increase in net cash used in investing activities was primarily due to lower maturities of short-term securities during the six months ended June 30, 2025.

Current wording

Net cash provided by investing activities for the nine months ended September 30, 2025 was $29.4 million as compared to $16.8 million used in investing activities for the nine months ended September 30, 2024. The decrease in net cash used in investing activities was primarily due to decreased investments in held-to-maturity securities during the nine months ended September 30, 2025. as compared to the nine months ended September 30, 2024.

Previous wording

Net cash used in financing activities for the six months ended June 30, 2025 was approximately $12.5 million as compared to net cash provided by financing activities of $0.1 million for the six months ended June 30, 2024. The increase in net cash used in financing activities during the six months ended June 30, 2025 is mainly due to the repurchase of stock under our share repurchase program.

Current wording

Net cash used in financing activities for the nine months ended September 30, 2025 was approximately $90.8 million as compared to net cash provided by financing activities of $134.6 million for the nine months ended September 30, 2024. Net cash used in financing activities during the nine months ended September 30, 2025 is mainly due the repurchase of stock under our share repurchase program. Net cash provided by financing activities during the nine months ended September 30, 2024 is mainly due to the proceeds from the new loan with Blue Owl, offset by the payoff of our prior loan with Hercules.
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Previous report — wording carried elsewhere

Interest Expense.*** ***Interest expense totaled $13.5 million for the six months ended June 30, 2025, as compared to $6.3 million for the six months ended June 30, 2024. The increase is mainly due to increased interest expense pertaining to the Initial Term Loan with Blue Owl during the period ended June 30, 2025 (see Note 7 - Loan Payable for more information).