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Item 5. Market for Registrant’s Common Equity

2026-02-27 compared with 2025-03-03 · 227 added, 175 removed, 172 unchanged (70% of the section changed)

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The following table provides information as of December 31, 2025, regarding the securities authorized for issuance under the TG Therapeutics, Inc.

Amended and Restated 2012 Incentive Plan (the 2012 Incentive Plan) and the TG Therapeutics, Inc.

2022 Incentive Plan (the 2022 Incentive Plan).

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Purchases of Equity Securities by the Issuer and Affiliated Purchasers

The following table summarizes our common stock repurchase activity during the fourth quarter of 2024:

Total Number of Shares (or Units) Purchased

Average Price Paid per Share (or Unit)

Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs

Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs*

October 1, 2024 through October 31, 2024

November 1, 2024 through November 30, 2024

December 1, 2024 through December 31, 2024

*Transaction fees are excluded.

In August 2024, the Company announced that its Board of Directors had authorized and approved a share repurchase program for up to $100 million of the currently outstanding shares of the Company’s common stock.

Repurchases under the program may be made using open market purchases, privately negotiated transactions, block purchases or other methods in accordance with applicable federal securities laws, including Rule 10b-18 of the Exchange Act.

Neither we nor any affiliated purchaser repurchased any of our equity securities during the quarter ended December 31, 2025.

On August 2, 2024, the Company announced that its Board of Directors had authorized and approved the Prior Share Repurchase Program for up to $100 million of the currently outstanding shares of the Company’s common stock.

Repurchases under the Prior Share Repurchase Program were made using open market purchases, privately negotiated transactions, block purchases or other methods in accordance with applicable federal securities laws, including Rule 10b-18 of the Exchange Act.

The Prior Share Repurchase Program did not have a fixed expiration date, may be suspended or discontinued at any time, and did not obligate us to acquire any particular amount of common stock.

On September 3, 2025, the Company announced the completion of the Prior Share Repurchase Program.

On September 3, 2025, the Company announced that its Board of Directors had authorized and approved the 2025 Share Repurchase Program for up to $100 million of the currently outstanding shares of the Company’s common stock.

Repurchases under the 2025 Share Repurchase Program may be made using open market purchases, privately negotiated transactions, block purchases or other methods in accordance with applicable federal securities laws, including Rule 10b-18 of the Exchange Act.

The 2025 Share Repurchase Program does not have a fixed expiration date, may be suspended or discontinued at any time, and does not obligate us to acquire any particular amount of our common stock.

We repurchased a total of approximately 0.3 million shares of our common stock for approximately $8.8 million under our share repurchase program for the year ended December 31, 2024.

Approximately $91.2 million remains available for repurchase of shares under the current authorized program.

Future repurchases of common stock will be dependent upon our financial position, results of operations, outlook, liquidity and other factors we deem relevant.

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

The following discussion and analysis contains forward-looking statements about our plans and expectations of what may happen in the future.

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

The following discussion and analysis contains forward-looking statements regarding our business, operations, financial condition, and prospects.

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

You should read the following discussion and analysis in conjunction with “Item 8.

Financial Statements and Supplementary Data,” and our consolidated financial statements beginning on page F-1 of this report.

TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell mediated diseases.

TG has received approval from the U.S.

Food and Drug Administration (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) and the Medicines and Healthcare products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom (UK), respectively.

TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases.

In addition to a research pipeline, TG Therapeutics has received approval from the U.S.

Food and Drug Administration (FDA) for BRIUMVI (ublituximab-xiiy) to treat adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval from several regulatory agencies outside of the U.S.

for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features.

We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities.

In February of 2021, we announced that the FDA granted accelerated approval of umbralisib, the Company’s PI3K delta inhibitor, then commercially referred to as UKONIQ, for the treatment of adult patients with relapsed or refractory MZL who have received at least one prior anti-CD20 based regimen and adult patients with relapsed or refractory FL who have received at least three prior lines of systemic therapy.

In April of 2022, we announced the voluntary withdrawal of UKONIQ from sale for the approved indications.

Our only source of product revenues during the year ended December 31, 2022 was from the sale of UKONIQ.

Our only source of product revenues during the years ended December 31, 2023 and 2024, was from the sale of BRIUMVI.

Product revenues are recorded net of estimates of variable consideration.

For further discussion of our revenue recognition policy, see “Critical Accounting Policies and Significant Judgements and Estimates” below.

Cost of revenue consists primarily of materials and third-party manufacturing costs, as well as freight and royalties owed to our licensing partner for BRIUMVI sales.

Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, a portion of the manufacturing costs of BRIUMVI units recognized as revenue during the years ended December 31, 2023 and 2024 were expensed prior to receipt of FDA approval on December 28, 2022, and therefore are not included in costs of product revenue during those periods.

Our other research and development expenses consist primarily of expenses relating to the design, development, manufacture, testing and enhancement of our drug candidates and technologies, milestone expenses related to in-licensing of new product candidates, fees paid to consultants and outside service providers for clinical and laboratory development, personnel expenses and other facilities-related expenses.

We expense our research and development costs as they are incurred.

Research and development expenses for the years ended December 31, 2024, 2023 and 2022 were approximately $83.1 million, $63.2 million and $112.1 million respectively, excluding noncash compensation expenses related to research and development.

Our selling, general and administrative expenses consist primarily of expenses related to the commercialization of our approved products, including salaries and related expenses for our commercialization team and commercial development activities.

Other selling, general and administrative expenses consist of executive, finance and other administrative personnel, recruitment expenses, professional fees and other corporate expenses, including investor relations, legal activities and facilities-related expenses.

Commercial Launch and Market Dynamics

BRIUMVI (ublituximab-xiiy), an anti-CD20 monoclonal antibody indicated for the treatment of relapsing forms of multiple sclerosis (RMS), was approved by the U.S.

Food and Drug Administration (FDA) in December 2022 and commercially launched in the United States in January 2023.

BRIUMVI is administered as a one-hour, twice per year infusion following the starting dose.

Since launch, our commercialization efforts have focused on expanding prescriber awareness, increasing penetration across infusion centers and neurology practices, securing payer coverage, and supporting patient access within a competitive RMS treatment landscape.

We believe BRIUMVI’s clinical profile, including its one-hour infusion time and twice-annual dosing schedule, together with demonstrated efficacy and safety in pivotal trials and accumulating real-world experience, supports its positioning within the anti-CD20 therapeutic class.

The anti-CD20 class represents a significant segment of the RMS market, reflecting physician familiarity with the mechanism of action and long-term treatment considerations.

Our ability to expand adoption is dependent on continued execution across access and site-of-care pathways;

however, uptake may be influenced by factors including established prescribing practices, patient switching dynamics, payer coverage and utilization management requirements, competitive contracting, site-of-care logistics, and evolving treatment guidelines.

In August 2023, we entered into a Commercialization Agreement with Neuraxpharm Pharmaceuticals, S.L.

(Neuraxpharm), pursuant to which Neuraxpharm obtained rights to commercialize BRIUMVI outside the United States.

Under the agreement, we are eligible to receive milestone payments, royalties and revenue from product supply to Neuraxpharm.

The timing and magnitude of ex-U.S.

revenues depend on country-specific regulatory approvals, pricing and reimbursement determinations, launch timing, and commercial uptake.

We provide development, regulatory, and other support services as required under the agreement to facilitate commercialization activities in applicable territories.

The RMS market is highly competitive and includes numerous approved disease-modifying therapies with varying mechanisms of action, routes of administration, safety profiles, and dosing schedules.

Competitive dynamics may be influenced by pricing and contracting strategies, payer utilization management practices, the introduction of new branded products or biosimilars, and broader healthcare system and macroeconomic conditions.

Our ability to continue to grow BRIUMVI revenues will depend on sustained physician adoption, patient persistence and adherence, competitive differentiation within the anti-CD20 class, and continued access across commercial and government payers.

Our net product revenue is subject to gross-to-net adjustments, including mandatory government discounts and rebates, contractual rebates and chargebacks, trade discounts and allowances (including cash discounts), product returns, distribution fees, and patient support programs.

These adjustments are influenced by payer mix, coverage determinations, contracting dynamics, and patient assistance utilization, and may fluctuate from period to period.

As our commercial footprint expands and payer contracting strategies evolve, the magnitude and variability of these adjustments may change.

Pipeline and Lifecycle Management

In addition to the ongoing commercialization of BRIUMVI, we continue to invest in our commercial organization, infrastructure, and internal capabilities to support lifecycle management and potential expansion of the product’s clinical and commercial profile.

A key area of focus is the development of a subcutaneous formulation of ublituximab, which is being evaluated as a potential alternative route of administration that may offer increased convenience and flexibility for patients and healthcare providers.

We are also exploring the use of BRIUMVI in autoimmune indications outside of MS and are advancing early-stage development activities for azer-cel in autoimmune diseases.

These programs reflect our broader strategy to enhance the durability of our portfolio and expand future therapeutic opportunities.

Beyond BRIUMVI, we continue to evaluate potential in-licensing and acquisition opportunities.

These opportunities may include earlier-stage programs, complementary products, proprietary technologies, or other therapeutic approaches that could enhance our pipeline and support long-term growth.

The scope, timing, and level of any such investments will depend on a range of factors, including scientific and clinical data, manufacturing feasibility, regulatory considerations, commercial readiness, available resources, and overall strategic and financial priorities.

Financial Overview and Key Components of our Operating Results

Although we have recently achieved profitability, we have historically incurred substantial operating losses since our inception and may continue to experience fluctuations in operating results.

Despite the commercialization of BRIUMVI and the potential future commercialization of other product candidates, there can be no assurance that we will maintain profitability on an ongoing basis.

For the twelve months ended December 31, 2025, we generated revenue of $616.3 million.

Historically, our operating losses have been driven primarily by expenses related to research and development programs and selling, general and administrative costs associated with our operations and commercialization activities to date.

Our operating results and cash flows have fluctuated in the past and may continue to vary significantly from period to period.

We will need to generate substantial revenues to sustain profitability and positive cash flow over the long term.

As of December 31, 2025, our accumulated deficit was approximately $1.1 billion, and we had $199.5 million in cash and cash equivalents, and investment securities.

Based on our current operating plan and results, we anticipate that our existing cash, cash equivalents, and investment securities, together with projected future revenues, will be sufficient to fund operations and meet our liquidity needs for more than twelve months after the date of issuance of this Annual Report on Form 10-K.

The actual level of cash required for operations will depend on numerous factors, including, among others, the scope of commercialization activities for BRIUMVI, the timing of collection of receivables from our customers on extended payment terms, the timing and design of clinical trials for our product candidates, and the costs associated with licensing or acquiring new product candidates.

We may seek significant additional financing in the future to support strategic initiatives and our ongoing and planned operations.

We expect our expenses to increase as we continue to grow and expand our clinical programs and pursue the potential commercialization of additional product candidates.

We anticipate incurring significant research and development expenses related to these activities for the foreseeable future.

The actual amount of cash needed to support these strategic initiatives will depend on many factors, including:

the timing and success of the ongoing commercialization of BRIUMVI and any other products for which we receive regulatory approval;

the costs and timing of clinical and commercial manufacturing supply arrangements for each product and product candidate;

the costs of expanding our sales, distribution, and other commercialization capabilities;

the costs and timing of regulatory approvals;

the progress of our clinical trials, including expenses to support the trials and milestone payments that may become payable under our license agreements;

our ability to establish and maintain strategic collaborations, including licensing and other arrangements;

the costs involved in enforcing or defending patent claims or other intellectual property rights;

the extent to which we in-license or invest in other indications or product candidates.

Cost of Revenue

Cost of revenue consists primarily of royalties owed to our licensing partner for BRIUMVI sales, materials and third-party manufacturing costs, freight, distribution and logistics expenses, and overhead costs associated with our supply chain.

Cost of revenue may also include excess or obsolete inventory adjustments, abnormal manufacturing costs, unabsorbed overhead, and manufacturing variances.

In accordance with our policy to expense costs associated with the manufacture of our products prior to regulatory approval, a portion of the manufacturing costs incurred to produce BRIUMVI before its FDA approval in December 2022 were expensed to research and development.

As a result, a portion of the BRIUMVI units recognized as revenue during the years ended December 31, 2025, 2024 and 2023 are not included in the cost of product revenue during those periods.

As commercialization continues and pre-approval inventory has been fully depleted, we expect cost of revenue and gross margin to normalize to levels that reflect current commercial manufacturing costs, royalty payments, and supply chain expenses.

Period-over-period fluctuations in cost of revenue may continue to occur based on the nature of our ordinary course of business operations, including production scheduling, manufacturing, inventory management, and the timing of overhead allocation.

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

Our other research and development expenses consist primarily of external clinical and manufacturing costs, personnel-related expenses, milestone and licensing payments, and overhead costs supporting development activities.

We recognize R&D costs as incurred.

These expenses include:

External development costs , including amounts paid to contract research organizations (CROs), contract manufacturing organizations (CMOs), central laboratories, clinical trial sites, and other third-party service providers supporting our preclinical studies, clinical trials, process development and analytical testing;

Manufacturing and scale-up costs , including costs associated with producing preclinical and clinical supply and performing process development and optimization activities.

Prior to FDA approval of BRIUMVI, all manufacturing costs for ublituximab were expensed to R&D as incurred.

Following approval, manufacturing costs related to commercial supply are capitalized as inventory;

Personnel and employee-related expenses , including salaries, benefits, travel and non-cash share-based compensation for employees engaged in research, clinical development, medical, regulatory and manufacturing-support functions;

Milestone, licensing and collaboration expenses , including upfront payments and milestone obligations incurred under in-license and collaboration agreements;

Facility and other overhead costs that support research and development activities.

S elling, General, and Administrative (SG&A) Expenses (Other)

Our other selling, general and administrative expenses consist primarily of expenses related to the commercialization of our approved products and the expenses required to maintain and support a growing commercial organization.

These expenses include:

Commercial operations costs , including salaries and related expenses, benefits, incentives, and travel for sales, marketing, and commercial development team, as well as promotional programs, marketing initiatives, medical affairs, and reimbursement support services related to BRIUMVI;

Corporate and administrative personnel costs , including compensation and related expenses for executive, finance, accounting, business development, legal, human resources, and other administrative functions;

Professional fees , including legal services, patent-related costs associated with the protection and maintenance of our intellectual property and propriety technologies, accounting and audit services, consulting services, external legal advisors, and other external advisors supporting our operations;

Corporate infrastructure and facilities costs , including rent, utilities, insurance, information technology systems, and other overhead necessary for our day to day operations and to support our commercial and administrative activities;

Additional SG&A support functions , such as medical affairs, legal activities, market access, reimbursement operations, and compliance.

Noncash Compensation Expense (R&D and SG&A)

Our results of operations include noncash compensation expenses as a result of stock-based compensation costs related to equity awards, restricted stock and options, granted to employees and non-employees.

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We recognize all stock-based payments to employees and non-employee directors (as compensation for service) as noncash compensation expense in the consolidated financial statements.

Forfeitures are recognized as they occur.

We recognize forfeitures as they occur.

RESULTS OF OPERATIONS

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Net income before taxes

Income tax benefit (expense)

Product Revenue, net .

Product revenue, net was approximately $606.9 million for the year ended December 31, 2025 compared to $313.7 million for the year ended December 31, 2024.

The increase in product revenue, net is driven by an increase in product shipments for BRIUMVI as a result of greater market penetration.

BRIUMVI, was commercially launched in the U.S.

in January 2023, following FDA approval.

Product revenue, net for both the year ended December 31, 2025 and 2024 consisted of net product sales of BRIUMVI in the United States of $594.1 million and $310.0 million, respectively.

Also included in product revenue, net for the year ended December 31, 2025 and 2024 are sales of BRIUMVI to our ex-U.S.

licensing partner, Neuraxpharm, of $12.8 million and $3.7 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.

License, Milestone, Royalty and Other Revenue.

License, milestone, royalty and other revenue was $9.4 million for the year ended December 31, 2025 compared to approximately $15.3 million for the year ended December 31, 2024.

License, milestone, royalty and other revenue for the year ended December 31, 2024 is comprised of a $12.5 million milestone payment under the Neuraxpharm Commercialization Agreement for the first key market commercial launch of BRIUMVI in the EU, as well as consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement.

License, milestone, royalty and other revenue for the year ended December 31, 2023 is predominantly comprised of recognition of the one-time $140.0 million non-refundable upfront payment under the Commercialization Agreement with Neuraxpharm (see Note 2 for more information).

License, milestone, royalty and other revenue for the year ended December 31, 2025 is comprised of $3.8 million consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement and $5.6 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 year ended December 31, 2024 is predominately comprised of the 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.

Cost of Revenue.

Cost of revenue for the year ended December 31, 2025 was $100.7 million compared to approximately $38.5 million for the year ended December 31, 2024.

Cost of revenue for both the years ended December 31, 2024 and December 31, 2023 consists primarily of third-party manufacturing, distribution, overhead costs and royalties owed to our licensing partner for BRIUMVI sales.

A portion of the costs of producing BRIUMVI sold to date 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 expect the cost of revenue for BRIUMVI to increase in relation to product revenues as we deplete these inventories.

We expect to use the remaining pre-commercialization inventory for product sales through the first quarter of 2025, after which our product gross margin is anticipated to decrease modestly.

The cost of revenue for the years ended December 31, 2024 and December 31, 2023 includes $2.4 million and $1.5 million, respectively, of costs related to delivering regulatory support and development services to Neuraxpharm in accordance with the Commercialization Agreement.

Cost of revenue for both the years ended December 31, 2025 and December 31, 2024 primarily consists 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 ended March 31, 2025 was expensed as research and development prior to the FDA approval of BRIUMVI and therefore is not reflected in the cost of revenue.

We depleted these inventories during the quarter ended March 31, 2025.

Cost of revenue for the quarter ended December 31, 2025 also includes a $6.2 million inventory reserve.

Noncash Compensation Expense (Research and Development).

Noncash compensation expense (research and development) related to equity incentive grants totaled $16.6 million for the year ended December 31, 2025, as compared to $11.2 million during the comparable period in 2024.

The decrease in noncash compensation expense was primarily due to decreased vesting of milestone-based grants during the year ended December 31, 2024, as compared to the year ended December 31, 2023.

The increase in noncash compensation expense was primarily due to greater recognition of noncash compensation expense for performance-based awards and the grant-date fair value of equity awards, including the impact of our increased stock price at which equity awards were granted, during the year ended December 31, 2025, as compared to the year ended December 31, 2024.

Other Research and Development Expense .

Other research and development expense increased for the year ended December 31, 2024, by approximately $19.9 million to $83.1 million as compared to the prior year ended December 31, 2023.

The increase in other research and development expense during the year ended December 31, 2024 was primarily attributable to manufacturing and development costs incurred in connection with our ublituximab subcutaneous development work, increased personnel and costs associated with the Precision License Agreement incurred during the period.

Other research and development expense totaled $143.6 million for the year ended December 31, 2025, as compared to $83.1 million during the prior year ended December 31, 2024.

The increase in research and development expense was primarily due to an increase in manufacturing expense, including manufacturing and development costs incurred in connection with our subcutaneous ublituximab development work, increased clinical trial related expenses pertaining to our clinical pipeline, and increased personnel costs during the period ended December 31, 2025, as compared to the year ended December 31, 2024.

This was partially offset by license and milestone expense incurred in 2024 pertaining to the Precision License Agreement.

Noncash Compensation Expense (Selling, General and Administrative).

Noncash compensation expense (selling, general and administrative) related to equity incentive grants totaled $31.4 million for the year ended December 31, 2024, as compared to $24.9 million during the comparable period in 2024.

The increase in noncash compensation expense was primarily due to greater recognition of noncash compensation expense for grants to executives during the year ended December 31, 2024.

Noncash compensation expense (selling, general and administrative) related to equity incentive grants totaled $48.1 million for the year ended December 31, 2025, as compared to $31.4 million during the comparable period ended December 31, 2024.

The increase in noncash compensation expense was primarily due to greater recognition of noncash compensation expense for performance and market-based equity awards, growth in headcount, and higher grant-date stock prices associated with equity awards granted during the year ended December 31, 2025, as compared to the year ended December 31, 2024.

Other Selling, General and Administrative.

Other selling, general and administrative expenses increased for the year ended December 31, 2024, by approximately $25.1 million to $122.9 million as compared to the prior year ended December 31, 2023.

The increase was primarily due to other selling, general and administrative costs, including personnel, consultants, and third parties associated with the commercialization of BRIUMVI during the year ended December 31, 2024.

Other selling, general and administrative expenses totaled $184.0 million increased for the year ended December 31, 2025, as compared to $122.9 million during the prior year ended December 31, 2024.

The increase was primarily due to marketing and media spend, and personnel-related costs associated with the commercialization of BRIUMVI during the year ended December 31, 2025.

Interest Expense.

Interest expense for the year ended December 31, 2025 was $26.7 million compared to $24.0 million for the comparable period ended December 31, 2024.

The $11.4 million increase is mainly due to $4.6 million of debt extinguishments costs incurred pertaining to the First Amendment with Hercules as well as increased interest expense pertaining to the Initial Term Loan with Blue during the same period (see Note 7 for more information).

The $2.7 million increase was primarily attributable to higher interest expense incurred under the Initial Term Loan with Blue Owl during the year ended December 31, 2025, as compared to interest expense incurred under the prior smaller loan agreement with Hercules, which was outstanding for a portion of the year ended December 31, 2024 (see Note 7 – Loan Payable for more information).

Other Income.

Other income increased by $3.1 million to $10.8 million for the year ended December 31, 2025, as compared to $7.7 million for the year ended December 31, 2024.

The increase is mainly due to greater accretion income earned from short-term investment securities during the year ended December 31, 2024, compared to the prior period.

Income Taxes.

Income tax increased by $1.8 million to $2.2 million for the year ended December 31, 2024, as compared to $0.4 for the year ended December 31, 2023.

The increase is due to state tax liabilities incurred during the year ended December 31, 2024.

The increase is mainly due to greater income earned from investments during the year ended December 31, 2025.

Income Tax Benefit (Expense).

Income tax benefit totaled $339.8 million for the year ended December 31, 2025, as compared to income tax expense of $2.2 million during the comparable period ended December 31, 2024.

The increase in income tax benefit is primarily driven by the release of our deferred tax asset valuation allowance during the year ended December 31, 2025.

Comparison of the Years Ended December 31, 2024 and 2023

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Product revenue, net

License, milestone and other revenue

License, milestone, royalty and other revenue

Total Revenue

Costs and expenses:

Cost of product revenue

Cost of revenue

Research and development:

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Total research and development

General and administrative:

Selling, general and administrative:

Noncash compensation

Other selling, general and administrative

Total general and administrative

Total selling, general and administrative

Total costs and expenses

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Total other expense, net

Net income (loss) before taxes

Net income (loss)

Net income before taxes

Income tax expense

Product Revenues, net .

Total revenue for the year ended December 31, 2023 increased compared to the comparable period ended December 31, 2022 primarily due to an increase in net product revenues from sales of our sole commercial product, BRIUMVI, which was commercially launched in the U.S.

P roduct revenue, net was approximately $313.7 million for the year ended December 31, 2024 compared to $92.0 million for the year ended December 31, 2023.

The increase in product revenue, net is driven by an increase in product shipments for BRIUMVI as a result of greater market penetration.

BRIUMVI, was commercially launched in the U.S.

in January 2023, following FDA approval.

Product revenue, net for the year ended December 31, 2022, consisted of net product sales of UKONIQ, which was officially withdrawn from the market in May 2022.

License Revenue .

License revenue was $140.2 million and $0.2 million for the years ended December 31, 2023 and December 31, 2022, respectively.

License revenue for the year ended December 31, 2023 is predominantly comprised of recognition of license revenue from the one-time $140.0 million non-refundable upfront payment recognized in the third quarter of 2023 as part of the Commercialization Agreement with Neuraxpharm (see Note 2 for more information).

License revenue for the year ended December 31, 2022 is comprised of recognition of a portion of the upfront payment from the ublituximab sublicense agreement with Ildong.

Other Revenue .

Other revenue was $1.5 million and zero for the year ended December 31, 2023 and December 31, 2022, respectively.

Other revenue for the year ended December 31, 2023 is comprised of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement.

Cost of Product Revenue.

Cost of revenue for the year ended December 31, 2023 increased compared to the comparable period ended December 31, 2022 due to increased product sales resulting from the commercial launch of BRIUMVI in the U.S.

market which began in January 2023 following FDA approval.

During the year ended December 31, 2023 the cost of revenue consisted primarily of third-party manufacturing, distribution, overhead costs and royalties on net sales of BRIUMVI owed to our licensing partner.

Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, a portion of the manufacturing costs of BRIUMVI units recognized as revenue during the year ended December 31, 2023 were expensed as research and development expenses prior to receipt of FDA approval, and therefore are not reflected in the cost of revenue.

We expect the cost of revenue for BRIUMVI to increase in relation to product revenues as we deplete these inventories and we expect to use the remaining pre-commercialization inventory for product sales through the first quarter of 2025.

License, milestone, royalty and other revenue was $15.3 million for the year ended December 31, 2024 compared to approximately $141.7 million for the year ended December 31, 2023.

Cost of Revenue.

Cost of revenue for the year ended December 31, 2024 was $38.5 million compared to approximately $14.1 million for the year ended December 31, 2023.

We depleted these inventories during the quarter ended March 31, 2025.

Noncash Compensation Expense (Research and Development).

Noncash compensation expense (research and development) related to equity incentive grants totaled $11.2 million for the year ended December 31, 2024, as compared to $13.0 million during the comparable period in 2023.

The decrease in noncash compensation expense was primarily due to decreased vesting of milestone-based grants during the year ended December 31, 2024, as compared to the year ended December 31, 2023.

Other Research and Development Expense .

Other research and development expense decreased for the year ended December 31, 2023, by approximately $48.9 million to $63.2 million as compared to the prior year ended December 31, 2022.

The decrease in other research and development expense during the year ended December 31, 2023 was primarily attributable to reduced manufacturing expense, a decrease in license milestones and reduced clinical trial related expenses.

Prior to the approval of BRIUMVI, manufacturing costs pertaining to BRIUMVI were expensed to research and development expense in the period incurred, and following approval are reflected in inventory.

Other research and development expense increased for the year ended December 31, 2024, by approximately $19.9 million to $83.1 million as compared to the prior year ended December 31, 2023.

Noncash Compensation Expense (Selling, General and Administrative).

Noncash compensation expense (selling, general and administrative) related to equity incentive grants totaled $24.9 million for the year ended December 31, 2023, as compared to $31.4 million during the comparable period in 2022.

The decrease in noncash compensation expense was primarily due to greater recognition of noncash compensation expense for grants to executives during the year ended December 31, 2022.

The increase in noncash compensation expense was primarily due to greater recognition of noncash compensation expense for grants to executives during the year ended December 31, 2024.

Other Selling, General and Administrative.

The increase was primarily due to other selling, general and administrative costs, including personnel and consultants, associated with the approval and commercialization of BRIUMVI, as well as increase in advisory fees pertaining to the Commercialization Agreement with Neuraxpharm during the year ended December 31, 2023.

Interest Expense.

Interest expense for the year ended December 31, 2024 was $24.0 million compared to $12.6 million for the comparable period ended December 31, 2023.

The $2.4 million increase is mainly due to greater interest expense related to First Amendment to the Amended Loan Agreement.

The $11.4 million increase is mainly due to $4.6 million of debt extinguishments costs incurred pertaining to the prior loan agreement with Hercules as well as increased interest expense pertaining to the Initial Term Loan with Blue Owl during the same period (see Note 7 for more information).

Other Income.

Other income increased by $2.7 million to $7.7 million for the year ended December 31, 2024, as compared to $5.0 million for the year ended December 31, 2023.

The increase is mainly due to greater accretion income earned from short-term investment securities during the year ended December 31, 2024, compared to the prior period.

Income Taxes.

Income tax increased by $0.4 million to $0.4 million for the year ended December 31, 2023, as compared to zero for the year ended December 31, 2022.

The $0.4 million increase is due to state tax liabilities incurred during the year ended December 31, 2023.

LIQUIDITY AND CAPITAL RESOURCES

Historically, we have incurred operating losses since our inception;

however, during the year ended December 31, 2024, and December 31, 2023 the Company generated net income.

During the year ended December 31, 2023, the Company experienced a net profit due to a $140.0 million non-refundable upfront payment recognized as license revenue in the third quarter of 2023 as part of our Commercialization Agreement with Neuraxpharm (see Note 2 for more information).

We may incur operating losses in the near term and may never become profitable.

As of December 31, 2024, we have an accumulated deficit of $1.5 billion.

Our major sources of cash have been proceeds from private placements and public offerings of equity securities, from our loan and security agreements, the upfront payment from the Commercialization Agreement (see Note 2 for more information), and from product revenue from drug sales of BRIUMVI.

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.

As of December 31, 2024, we generated $313.7 million in product revenue from sales of BRIUMVI.

BRIUMVI first became commercially available in the United States in January 2023.

Even with the commercialization of BRIUMVI and the possible future commercialization of our other drug candidates, we may not realize continued profitability.

Our ability to achieve continued profitability depends on our ability to generate revenue and many other factors, including our ability to successfully commercialize our drug candidates alone or in partnership;

successfully complete any post-approval regulatory obligations and our ability to maintain or obtain regulatory approval for our drug candidates.

We may incur operating losses even now that we are generating revenues from BRIUMVI.

As of December 31, 2024, we had $311.0 million in cash and cash equivalents, and short-term investment securities.

We anticipate that our cash, cash equivalents, and investment securities as of December 31, 2024, combined with projected revenues associated with the sale of BRIUMVI in the U.S.

and ex-U.S., will provide sufficient liquidity for more than a twelve-month period from the date of filing this Annual Report on Form 10-K.

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, including the commercialization of any of our drug candidates.

Income tax expense increased by $1.8 million to $2.2 million for the year ended December 31, 2024, as compared to $0.4 million for the year ended December 31, 2023.

The increase is due to state tax liabilities incurred during the year ended December 31, 2024.

Material Cash Requirements and Contractual Obligations

Our material cash requirements primarily relate to the continued commercialization of BRIUMVI, including commercial operations, manufacturing and supply commitments, medical affairs activities, post-marketing requirements, and ongoing clinical development programs, as well as general and administrative expenses supporting our commercial-stage operations.

Certain of these requirements arise from contractual commitments, while others are driven by our operating plan and the ordinary course of business.

We expect to fund these expenditures through existing cash, cash equivalents and investment securities, cash flows from BRIUMVI product sales, and, if needed, access to additional capital under the uncommitted portion of our term loan facility with Blue Owl or other financing sources.

As of December 31, 2025, our contractual obligations consist primarily of purchase and supply commitments supporting the commercial and clinical manufacture of BRIUMVI.

Certain of these agreements include non-cancelable provisions, minimum purchase requirements, or binding forecast commitments.

We also maintain lease obligations for our office facilities in New York and North Carolina, which are expected to be funded through operating cash flows.

In addition, we are obligated to make interest and future principal payments under our term loan with Blue Owl, including scheduled quarterly amortization beginning in 2028.

The timing and amount of payments may vary based on applicable interest rates and certain performance-related provisions.

We also enter into collaboration and license agreements that may require future milestone and royalty payments.

Because these payments are contingent upon the achievement of specified events, they are not included in our contractual commitments but could become material in future periods.

Based on our current operating plan, financial resources, and projected results, we believe we have sufficient liquidity to fund operations and meet our material cash requirements for at least the next twelve months from the issuance of this Annual Report on Form 10-K.

However, future capital requirements will depend on a number of factors, and additional financing may be required

Discussion of Cash Flows

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Net cash used in operating activities

Net cash used in investing activities

Net cash provided by (used in) financing activities

Cash used in operating activities for the year ended December 31, 2024 was $40.5 million as compared to $31.4 million for the year ended December 31, 2023.

The increase in net cash used in operating activities was due to higher operating expenditures and an increase in cash used for inventory purchases during the year ended December 31, 2024.

For the year ended December 31, 2024, net cash used in investing activities was $1.0 million as compared to $50.7 million for the year ended December 31, 2023.

The decrease in net cash used in investing activities was primarily due to lower maturities of short-term securities during the year ended December 31, 2023, mainly based on timing of maturities.

For the year ended December 31, 2024, net cash provided by financing activities was $128.5 million as compared to $72.7 million for the year ended December 31, 2023.

The increase in net cash provided by financing activities during the year ended December 31, 2024 is mainly due to the proceeds from the new loan with Blue Owl, offset by the payoff of our prior loan with Hercules.

On September 2, 2022, we filed an automatic “shelf registration” statement on Form S-3 (the 2022 WKSI Shelf) as a “well-known seasoned issuer” as defined in Rule 405 under the Securities Act, which registered an unlimited and indeterminate amount of debt or equity securities for future issuance and sale.

The 2022 WKSI Shelf was declared effective in September 2022.

In connection with the 2022 WKSI Shelf, we entered into an At-the-Market Issuance Sales Agreement (the 2022 ATM) with Cantor Fitzgerald & Co.

Net cash provided by (used in) investing activities

Net cash (used in) provided by financing activities

Net cash used in operating activities for the year ended December 31, 2025 was $24.8 million as compared to cash used in operating activities of $40.5 million for the year ended December 31, 2024, representing a $15.7 million improvement year over year.

The improvement was driven by higher net income in 2025, $447.2 million compared to $23.4 million in 2024, partially offset by a large non-cash deferred income tax benefit recorded in 2025 of $348.0 million.

Operating cash flow also benefited from favorable working capital changes, including a decrease in inventory purchases, a $33.4 million year-over-year improvement, and an increase in accounts payable and accrued expenses, a $33.1 million improvement.

These favorable impacts were partially offset by an increase in accounts receivable and other current assets in 2025 compared to 2024, which reduced operating cash flow year over year.

Overall, the reduced use of cash in operating activities reflects improved underlying operating performance and certain favorable working capital movements, partially offset by timing-related changes in receivables and other current assets.

Net cash provided by investing activities for the year ended December 31, 2025 was $13.8 million as compared to $1.0 million used in investing activities for the year ended December 31, 2024.

The increase in net cash used in investing activities was primarily due to decreased investments in held-to-maturity securities during the year ended December 31, 2025 as compared to the year ended December 31, 2024.

Net cash used in financing activities for the year ended December 31, 2025 was approximately $89.7 million as compared to net cash provided by financing activities of $128.5 million for the year ended December 31, 2024.

Net cash used in financing activities during the year ended December 31, 2025 is mainly due to the repurchase of stock under our share repurchase program.

Net cash provided by financing activities during the year ended December 31, 2024 is mainly due to the proceeds from the loan with Blue Owl, offset by the payoff of our prior loan with Hercules.

On August 8, 2025, we filed an automatic “shelf registration” statement on Form S-3 (the 2025 WKSI Shelf) as a WKSI as defined in Rule 405 under the Securities Act of 1933, as amended.

The 2025 WKSI Shelf was declared effective upon filing and registers an unlimited amount of debt securities, equity securities, or other securities that we may issue and sell from time to time.

The at-the-market program established under our prior shelf registration statement on Form S-3 pursuant to the At-the-Market Issuance Sales Agreement, dated September 2, 2022, with Cantor Fitzgerald & Co.

Riley Securities, Inc.

(each a 2022 Agent and collectively, the 2022 Agents), relating to the sale of shares of our common stock.

Under the 2022 ATM, we will pay the 2022 Agents a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of common stock.

The 2022 ATM is our only active ATM program.

During the year ended December 31, 2023, we sold a total of 1,385,700 shares of common stock under the 2022 ATM for aggregate total gross proceeds of approximately $47.1 million at an average selling price of $34.01 per share, resulting in net proceeds of approximately $46.3 million after deducting commissions and other transactions costs.

We had no activity on the 2022 ATM during the year ended December 31, 2024.

The 2022 WKSI Shelf is currently our only active shelf registration statement.

We may offer any combination of the securities registered under the 2022 WKSI Shelf from time to time in response to market conditions or other circumstances if we believe such a plan of financing is in the best interests of our stockholders.

We may need to file additional shelf registration statements in the future to provide us with the flexibility to raise additional capital to finance our operations as needed.

We may offer and sell securities registered under the 2025 WKSI Shelf in one or more offerings, from time to time, depending on market conditions and our capital needs.

We may also file additional registration statements in the future to maintain financing flexibility in support of our operations.

Debt Financings

On March 31, 2023 (the First Amendment Effective Date), the Company entered into a First Amendment to the Amended and Restated Loan and Security Agreement (the First Amendment) with Hercules Capital, Inc.

The First Amendment amended the terms of the Amended and Restated Loan and Security Agreement (Amended Loan Agreement) with Hercules that closed on December 30, 2021.

The First Amendment amended the terms of the Amended Loan Agreement to, among other things, (i) issue an advance of $25.0 million drawn at the First Amendment Effective Date (the Tranche 3A Advance), (ii) provide for the formal expiration of Tranche 2, (iii) change the draw amounts and dates available under subsequent tranches, including splitting the remaining balance of Tranche 3 into two additional advances in an aggregate principal amount of up to $20.0 million, in increments of $10.0 million (a Tranche 3B Advance and a Tranche 3C Advance), decreasing the amount available under Tranche 4 from $65.0 million to $60.0 million, and adding a Tranche 5 of $25.0 million, subject to the achievement of revenue related performance milestones, (iv) extend the interest only period from February 1, 2025 to August 1, 2025 and (v) modify the cash interest rate to be the greater of either (a) the “prime rate” as reported in The Wall Street Journal plus 1.20%, and (b) 8.95%.

In addition to the cash interest rate, the principal balance will accrue paid-in-kind interest at a rate of 2.25%, which amount will be capitalized and added to the outstanding principal balance of the Amended Term Loan and payable at the maturity date of the Amended Loan Agreement, as amended, The Amended Loan Agreement, as amended, contains financial covenants that require the Company to maintain certain levels of unrestricted cash and additional financial covenants related to market capitalization.

The Amended Loan Agreement, as amended also contains warrant coverage of 2.95% of the total amount funded.

A warrant (the Warrant) was issued by the Company to Hercules to purchase 115,042 shares of common stock with an exercise price of $17.95 for the initial amount funded at the Closing Date.

The Warrant shall be exercisable for seven years from the date of issuance.

Hercules may exercise the Warrant either by (a) cash or check or (b) through a net issuance conversion.

Additionally, a warrant was issued by the Company to Hercules to purchase 50,172 shares of common stock with an exercise price of $14.70 for the amount funded pertaining to the Tranche 3A Advance (the First Amendment Warrant).

The First Amendment Warrant shall be exercisable for seven years from the date of issuance.

Hercules may exercise the First Amendment Warrant either by (a) cash or check or (b) through a net issuance conversion.

On August 2, 2024 (the New Closing Date), the Company entered into a term loan facility of $250 million (the Initial Term Loan) with Blue Owl Capital Corporation, as administrative agent (the Administrative Agent), HealthCare Royalty and Blue Owl Capital under the Financing Agreement (as defined below).

The Company repaid all outstanding principal and accrued interest and fees under the First Amendment with Hercules (such repayment, the Refinancing), which Refinancing was funded with the proceeds of the Initial Term Loan.

The existing Amended Loan Agreement with Hercules was effectively terminated, and all guarantees and liens granted thereunder were released upon the consummation of the Refinancing.

The Initial Term Loan is governed by a financing agreement, dated as of the New Closing Date (the Financing Agreement), which provides for (i) a single draw of the Initial Term Loan on the New Closing Date and (ii) an uncommitted additional facility in an aggregate principal amount of up to $100 million.

On August 2, 2024 (the New Closing Date), we entered into a term loan facility of $250 million (the Initial Term Loan) with Blue Owl Capital Corporation, as administrative agent (the Administrative Agent), HealthCare Royalty and Blue Owl Capital under the Financing Agreement (as defined below) to repay all outstanding principal and accrued interest and fees under our prior loan agreement with Hercules.

The Initial Term Loan is governed by a financing agreement (the Financing Agreement), which provides for (i) a single draw of the Initial Term Loan, which was funded on August 2, 2024, and (ii) an uncommitted additional facility in an aggregate principal amount of up to $100 million.

The Initial Term Loan will mature on August 2, 2029 (the Term Loan Maturity Date).

The Initial Term Loan accrues interest at a per annum rate of interest equal to an applicable margin plus, at the Company’s option, either (a) at a base rate determined by reference to the highest of (1) the prime rate published by the Wall Street Journal, (2) the federal funds effective rate plus 0.50% and (3) Term SOFR, plus 1.00% or (b) Term SOFR, which, shall be no less than 1.00%.

The applicable margin for borrowings of the Initial Term Loan is determined on a quarterly basis by reference to a pricing grid based on the achievement of US Net Sales (as defined in the Financing Agreement) for the most recently completed four consecutive fiscal quarters of the Company and its Subsidiaries (as defined in the Financing Agreement).

The pricing grid commences at 5.50% for SOFR borrowings and 4.50% for base rate borrowings and is subject to a 25-basis point step-down upon achievement of a specified US Net Sales threshold.

The Initial Term Loan accrues interest at a per annum rate of interest equal to an applicable margin plus, at our option, either (a) a base rate determined by reference to the highest of (1) the prime rate published by the Wall Street Journal, (2) the federal funds effective rate plus 0.50% and (3) Term SOFR, plus 1.00% or (b) Term SOFR, which shall be no less than 1.00%.

The applicable margin for borrowings of the Initial Term Loan is determined on a quarterly basis by reference to a pricing grid based on the achievement of U.S.

Net Sales (as defined in the Financing Agreement) for the most recently completed four consecutive fiscal quarters.

The pricing grid commences at 5.50% for SOFR borrowings and 4.50% for base rate borrowings and is subject to a 25 basis point step-down upon achievement of a specified U.S.

Net Sales threshold.

The Initial Term Loan requires scheduled quarterly amortization payments, commencing with the fiscal quarter ending June 30, 2028, in an amount equal to $12.5 million, with the balance due and payable on the Term Loan Maturity Date; provided that such amortization payments may be deferred to the Term Loan Maturity Date upon the achievement of a Total Net Leverage Ratio (as defined in the Financing Agreement) that is less than or equal to an agreed threshold.

The Initial Term Loan is secured by a lien on substantially all of the assets of the Company and certain subsidiaries of the Company as guarantors and contains customary covenants and representations.

The Initial Term Loan is secured by a lien on substantially all of our assets and by guarantees from certain of our subsidiaries and contains customary covenants and representations.

As of December 31, 2025, we were in compliance with all financial covenants.

The events of default under the Financing Agreement are customary for financings of this type.

If an event of default occurs, the Administrative Agent is entitled to take enforcement action, including acceleration of amounts due under the Financing Agreement.

The Company evaluated whether the Initial Term Loan represented a debt modification or extinguishment of the First Amendment with Hercules with ASC 470-50, Debt – Modifications and Extinguishments.

As a result of the Initial Term Loan and effective termination of the First Amendment with Hercules, this transaction was accounted for by the Company under the extinguishment accounting model.

The Company recorded a loss on extinguishment of debt of approximately $4.6 million in the Company’s statement of operations for the three and nine months ended September 30, 2024, representing the write-off of unamortized debt issuance costs and a prepayment charge.

The Company capitalized third party fees from the Initial Term Loan to debt issuance costs and capitalized the facility fee incurred with the Administrative Agent as part of the Initial Term Loan to debt discount.

The Company incurred total financing and upfront costs of $6.0 million related to the Initial Term Loan which are recorded as debt issuance costs and debt discount costs and as an offset to loan payable on the Company’s consolidated balance sheet.

The debt issuance and debt discount costs are being amortized over the term of the debt using the straight-line method, which approximates the effective interest method, and will be included in interest expense in the Company’s consolidated statements of operations.

Amortization of debt issuance and debt discount costs was $5.6 million (including write off of remaining debt issuance balance under the First Amendment with Hercules), $2.4 million and $1.8 million for the years ended December 31, 2024, 2023 and 2022, respectively.

We evaluated whether the Initial Term Loan represented a debt modification or extinguishment of our prior loan agreement with Hercules with ASC 470-50, Debt – Modifications and Extinguishments.

As a result of the Initial Term Loan and effective termination of our prior loan agreement with Hercules, this transaction was accounted for by us under the extinguishment accounting model.

We recorded a loss on extinguishment of debt of approximately $4.6 million in our statement of operations for the year ended December 31, 2024, representing the write-off of unamortized debt issuance costs and a prepayment charge.

We capitalized third party fees from the Initial Term Loan to debt issuance costs and capitalized the facility fee incurred with the Administrative Agent as part of the Initial Term Loan to debt discount.

We incurred total financing and upfront costs of $6.0 million related to the Initial Term Loan, which are recorded as debt issuance costs and debt discount costs and presented as an offset to loan payable on our consolidated balance sheet.

The debt issuance and debt discount costs are being amortized over the term of the debt using the straight-line method, which approximates the effective interest method, and are included in interest expense in our consolidated statements of operations.

Amortization of debt issuance and debt discount costs was $1.2 million, $2.0 million, and $2.4 million for the years ended December 31, 2025, 2024 and 2023, respectively.

At December 31, 2025, the remaining unamortized balance of debt issuance and debt discount costs was $4.4 million.

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The Office Agreement requires us to pay our respective share of the average annual rent and other costs of the 15-year lease.

We approximate an average annual rental obligation of $1.8 million under the Office Agreement.

We began to occupy this new space in April 2016, with rental payments beginning in the third quarter of 2016.

Also in connection with this lease, we have pledged $1.3 million to secure a line of credit as a security deposit for the Office Agreement, which has been recorded as restricted cash in the accompanying consolidated balance sheets.

We estimate an average annual rental obligation of $1.8 million under the Office Agreement.

We began to occupy this office space in April 2016, with rental payments beginning in the third quarter of 2016.

In connection with the Office Agreement, we pledged $1.3 million to secure a line of credit as a security deposit, which is recorded as restricted cash in the accompanying consolidated balance sheets.

In February 2026, FBIO entered into a sublease agreement with a third party for the entirety of the New York City office space subject to the Office Agreement.

The Company remains obligated under the Office Agreement to pay its respective share of the rent and other related costs through the expiration of the lease term.

Under the terms of the arrangement, the Company may be required to fund its proportionate share of any shortfall between the head lease obligations and sublease income.

This transaction is expected to significantly reduce the Company’s net rent expense prospectively.

Total rental expense was approximately $1.9 million, $2.3 million and $2.2 million for the years ended December 31, 2025, 2024 and 2023, respectively.

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generally accepted accounting principles.

The preparation of these financial statements requires us to make estimates and judgments that affect the reported amount of assets and liabilities and related disclosure of contingent assets and liabilities at the date of our financial statements and the reported amounts of revenues and expenses during the applicable period.

The preparation of these financial statements requires us to make estimates and judgments that affect the reported amount of assets and liabilities and the related disclosures of contingent assets and liabilities at the date of our financial statements and the reported amounts of revenues and expenses during the applicable period.

Actual results may differ from these estimates under different assumptions or conditions.

We define critical accounting policies as those that are reflective of significant judgments and uncertainties and which may potentially result in materially different results under different assumptions and conditions.

In applying these critical accounting policies, our management uses its judgment to determine the appropriate assumptions to be used in making certain estimates.

We define critical accounting policies as those involving significant judgments and uncertainties and which may potentially result in materially different results under different assumptions and conditions.

In applying these critical accounting policies, management exercises judgement to determine the appropriate assumptions to be used in making certain estimates.

These estimates are subject to an inherent degree of uncertainty.

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Revenue Recognition .

Pursuant to Topic 606, we recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.

Pursuant to Topic 606, we recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration we expect to be entitled in exchange for those goods or services.

To achieve this core principle, Topic 606 includes provisions within a five-step model that includes (i) identifying the contract with a customer, (ii) identifying the performance obligations in the contract, (iii) determining the transaction price, (iv) allocating the transaction price to the performance obligations, and (v) recognizing revenue when, or as, an entity satisfies a performance obligation.

At contract inception, we assess the goods or services promised within each contract and assess whether each promised good or service is distinct and determine those that are performance obligations.

At contract inception, we assess the goods or services promised within each contract and determine which promised good or service is distinct and therefore considered a performance obligation.

We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied.

Product Revenue, Net – The Company recognizes product revenues, net of variable consideration related to certain allowances and accruals, when the customer takes control of the product, which is typically upon delivery to the customer.

Product Revenue, Net .

We recognize product revenues, net of variable consideration related to certain allowances and accruals, when the customer takes control of the product, which is typically upon delivery to the customer.

Product revenue is recorded at the net sales price, or transaction price.

The Company records product revenue reserves, which are classified as a reduction in product revenues, to account for the components of variable consideration.

We record product revenue reserves, which are classified as a reduction in product revenues, to account for the components of variable consideration.

Variable consideration includes the following components, which are described below:

chargebacks, government rebates, trade discounts and allowances, product returns, and co-payment assistance.

These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is expected to be settled with a credit against the Company's customer account) or a liability (if the amount is expected to be settled with a cash payment).

The Company's estimates of reserves established for variable consideration are calculated based upon a consistent application of the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts.

These estimates reflect the Company's current contractual requirements, customer channel mix, changes to product price, government pricing calculations, and industry data.

The amount of variable consideration that is included in the transaction price may be subject to constraint and is included in net product revenues only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period.

Actual amounts of consideration received may ultimately differ from the Company's estimates.

If actual results vary, the Company adjusts these estimates, which could have an effect on earnings in the period of adjustment.

chargebacks, government rebates, commercial payer rebates, trade discounts and allowances, product returns, and co-payment assistance.

These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is expected to be settled with a credit against our customer account) or a liability (if the amount is expected to be settled with a cash payment).

Our estimate of reserves for variable consideration is calculated using a consistent application of the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts.

These estimates reflect our current contractual requirements, customer channel mix, changes to product price, government pricing calculations, and industry data.

The amount of variable consideration included in the transaction price may be subject to constraint and is included in net product revenues only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period.

Actual amounts of consideration received may ultimately differ from our estimates.

If actual results vary, we adjust these estimates, which could have an effect on earnings in the period of adjustment.

For a complete discussion of the accounting for product revenue, see Note 1 – Organization and Summary of Significant Accounting Policies in the Notes to Consolidated Financial Statements.

License Revenue - Revenue recognized from license agreements will include royalties on sales, upfront, milestone and other payments, if any, under any current or future licensing agreements, including revenues related to the supply of our drug candidates or approved drugs to our various licensing partners under these types of contracts.

License Revenue.

Revenue recognized from license agreements may include royalties on sales, upfront, milestone and other payments, if any, under any current or future licensing agreements, including revenues related to the supply of our drug candidates or approved drugs to our various licensing partners under these types of contracts.

For a complete discussion of the accounting for license revenue, see Note 1 – Organization and Summary of Significant Accounting Policies in the Notes to Consolidated Financial Statements.

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We recognize all stock-based payments to employees and non-employee directors (as compensation for service) as noncash compensation expense in the consolidated financial statements.

Forfeitures are recognized as they occur.

We recognize forfeitures as they occur.

Accrued Research and Development Expenses .

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Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in us reporting amounts that are too high or too low in any particular period.

Income Taxes .

We recognize deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns.

Deferred tax assets and liabilities are determined as the difference between the tax basis of assets and liabilities and their respective financial reporting amounts (“temporary differences”) at enacted tax rates in effect for the years in which the differences are expected to reverse.

A valuation allowance is established for deferred tax assets for which it is more likely than not that some portion or all of the deferred tax assets will not be realized.

We periodically re-assess the need for a valuation allowance against our deferred tax assets based on all available evidence, including scheduled reversals of deferred tax liabilities, projected future taxable income, tax planning strategies, results of recent operations, and our historical earnings experience by taxing jurisdiction.

Significant judgment is required in making this assessment.

We recognize the financial statement effects of a tax position when our assessment is that there is more than a 50% probability that the position will be sustained upon examination by a taxing authority based upon its technical merits.

Uncertain tax positions are recorded based upon certain recognition and measurement criteria.

Significant judgment is required in making this assessment, and, therefore, we re-evaluate uncertain tax positions and consider various factors, including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, information obtained during in-process audit activities, and changes in facts or circumstances related to a tax position.

We adjust the amount of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain tax positions.

RECENTLY ISSUED ACCOUNTING STANDARDS

In November 2023, the FASB issued ASU No.

2023-07, Segment Reporting—Improvements to Reportable Segment Disclosures, which improves reportable segment disclosure requirements, primarily through enhanced disclosures about segment expenses categorized as significant or regularly provided to the Chief Operating Decision Maker (CODM).

The amendments in ASU No.

2023-07 apply to public entities, including those with a single reportable segment, and are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted.

The Company has evaluated the impact ASU No.

2023-07 on its consolidated financial statements.

The Company has adopted this standard as of December 31, 2024 and noted there was no material impact on the Company's consolidated financial statements.

The adoption did result in enhanced disclosures as included in Note 1 - Organization and Summary of Significant Accounting Policies .

Please refer to Note 1 – Organization and Summary of Significant Accounting Policies in the Notes to Consolidated Financial Statements for further discussion.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 5. Market for Registrant’s Common Equity