What changed in this filing

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Item 5. Market for Registrant’s Common Equity

2025-03-03 compared with 2024-02-29 · 153 added, 111 removed, 194 unchanged (58% of the section changed)

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The number of record holders of our common stock as of February 25, 2025 was 204.

We have never declared or paid any cash dividends on our common stock and do not anticipate paying any cash dividends in the foreseeable future.

We have never declared or paid any cash dividends on our common stock.

Any future determination to pay dividends will be at the discretion of our board of directors.

Securities Authorized for Issuance Under Equity Compensation Plans

The following table provides information as of December 31, 2023, regarding the securities authorized for issuance under our equity compensation plans, the TG Therapeutics, Inc.

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

The following table provides information as of December 31, 2024, regarding the securities authorized for issuance under the TG Therapeutics, Inc.

2022 Incentive Plan (the 2022 Incentive Plan).

There were no additional shares available to be issued under the 2012 Incentive Plan.

Equity Compensation Plan Information

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For information about all of our equity compensation plans see Note 6 to our Consolidated Financial Statements included in this report.

COMMON STOCK PERFORMANCE GRAPH

Stock Performance Graph

The following graph compares the cumulative total stockholder return on our common stock for the period from December 31, 2019 through December 31, 2024, with the cumulative total return over such period on (i) the U.S.

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Fiscal Years ending December 31.

REMOVED AND RESERVED

Sale of Unregistered Securities

Not applicable.

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.

The 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.

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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 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 RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

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.

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

On February 5, 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.

On April 15, 2022, we announced the voluntary withdrawal of UKONIQ from sale for the approved indications.

During the year ended December 31, 2023, our only sources of product revenues were from the sales of BRIUMVI.

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.

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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 year ended December 31, 2023 were expensed prior to receipt of FDA approval on December 28, 2022, and therefore are not included in costs of product revenue during the current period.

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.

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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.

The following table sets forth the research and development expenses per project, exclusive of noncash compensation expenses, for the periods presented.

(in thousands)

Early Clinical Pipeline & Pre-Clinical

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

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.

Our results of operations include noncash compensation expenses as a result of the grants of restricted stock and stock options.

Compensation expense for awards of restricted stock and stock options granted to employees and directors represents the fair value of the award recorded over the respective vesting periods of the individual awards.

The expense is included in the respective categories of expense in the consolidated statements of operations.

We expect to continue to incur significant noncash compensation expenses.

We recognize all share-based payments to employees and non-employee directors (as compensation for service) as noncash compensation expense in the consolidated financial statements based on the fair values of such payments.

Stock-based compensation expense recognized each period is based on the value of the portion of share-based payment awards that is ultimately expected to vest during the period.

Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

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.

Stock-based compensation costs are measured at the date of grant based on the fair value of the award.

We estimate the grant date fair value of options, and the resulting stock-based compensation expense, using the Black-Scholes option-pricing model.

Equity awards with market conditions are valued using advanced option-pricing models, such as a Monte Carlo simulation.

The effect of a market condition is reflected in the award’s fair value on the grant date.

For time-based or performance-based restricted stock, the fair value is based on the market value of our common stock on the date of grant.

Stock-based compensation expense for time-based restricted stock and options is recognized on a straight-line basis over the requisite service period.

Stock-based compensation expense for awards that vest upon the achievement of milestones is recognized over the requisite service period when the achievement of such milestones becomes probable.

Stock-based compensation expense for an award that has a market condition is recognized over the requisite service period, which is derived from the valuation model, even if the market condition is never satisfied.

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.

RESULTS OF OPERATIONS

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Product revenue, net

License, milestone and other revenue

License, milestone, royalty and other revenue

Total Revenue

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Total other expense, net

Net income (loss) before taxes

Net income (loss)

Net income before taxes

Product Revenue, net .

Product revenue, net increased for the year ended December 31, 2023 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.

Product 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.

License, Milestone, Royalty and Other Revenue.

License, milestone, royalty and other revenue was $15.3 million for the year ended December 30, 2024 compared to approximately $141.7 million for the year ended December 31, 2023.

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).

Cost of 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 half of 2025

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.

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.

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.

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.

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 vesting of milestone-based grants and a decrease in forfeitures during the year ended December 31, 2023 compared to 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.

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 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.

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.

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 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).

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.

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.

Comparison of the Years Ended December 31, 2023 and 2022

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Product revenue, net

License revenue

License, milestone and other revenue

Total Revenue

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Total other expense, net

Total revenue for the year ended December 31, 2022 decreased compared to the comparable period ended December 31, 2021 due to a decrease in net product revenues resulting from the voluntary withdrawal from the U.S.

market of our sole commercial product, UKONIQ.

Net income (loss) before taxes

Net income (loss)

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.

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, 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.

Cost of Product Revenue.

Cost of product revenue for the year ended December 31, 2022 decreased compared to the comparable period ended December 31, 2021 due to the stoppage of product sales resulting from the withdrawal from the U.S.

market of our sole commercial product UKONIQ.

During the year ended December 31, 2022 the cost of product revenue consists primarily of freight and royalties on net sales of UKONIQ owed to our licensing partner.

Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, the manufacturing costs of UKONIQ units recognized as revenue during the year ended December 31, 2022 were expensed as research and development expenses prior to receipt of FDA approval on February 5, 2021, and therefore are not included in costs of product revenue during the current period.

market which began in January 2023 following FDA approval.

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.

Noncash Compensation Expense (Research and Development).

Noncash compensation expense (research and development) related to equity incentive grants totaled $13.0 million for the year ended December 31, 2023, as compared to $13.2 million during the comparable period in 2022.

The decrease in noncash compensation expense was primarily due to forfeitures of restricted stock during the year ended December 31, 2022, as well as an overall decreased headcount during the year ended December 31, 2022 compared to the year ended December 31, 2021.

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 research and development expense is primarily attributable to reduced clinical trial related expenses, headcount, lower fees paid to consultants and outside service providers, license milestones and decreased manufacturing expense during the year ended December 31, 2022.

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.

Other Selling, General and Administrative.

Other selling, general and administrative expenses decreased for the year ended December 31, 2022, by approximately $26.8 million to $64.0 million as compared to the prior year ended December 31, 2021.

The decrease was due primarily to lower other selling, general and administrative costs, as a result of our withdrawal of UKONIQ and decreased headcount, during the period ended December 31, 2022.

Other selling, general and administrative expenses increased for the year ended December 31, 2023, by approximately $33.9 million to $97.8 million as compared to the prior year ended December 31, 2022.

Interest Expense.

Interest expense for the year ended December 31, 2023 was $12.6 million compared to $10.2 million for the comparable period ended December 31, 2022.

The $4.6 million increase is mainly due to greater interest expense related to the Amended Loan Agreement entered into in December 2021.

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

Other Income.

Other income increased by $0.3 million to $5.0 million for the year ended December 31, 2023, as compared to $4.7 million for the year ended December 31, 2022.

The increase is mainly due to greater interest income, as well as a research & development tax credit refund received by our Australian subsidiary during the year ended December 31, 2022.

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, the Company experienced a net profit during the twelve months ended December 31, 2023 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 expect to continue to incur operating losses in the near term and may never become profitable.

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 executed with Hercules (see Note 7 for more information), and the upfront payment from the Commercialization Agreement (see Note 2 for more information).

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 2023, we had generated $ 92 .0 million in product revenue from sales of BRIUMVI.

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

Even with the commercialization of BRIUMVI and the possible future commercialization of our other drug candidates, we may not become profitable.

Our ability to achieve 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;

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 continue to incur operating losses even now that we are generating revenues from BRIUMVI.

As of December 31, 2023, we had $217.5 million in cash and cash equivalents, and investment securities.

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, preparations for the potential commercialization of our other drug candidates, 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.

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.

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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 decrease in cash used in operating activities was due primarily to the one-time upfront payment of $140.0 million from Neuraxpharm, as part of the Commercialization Agreement during 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 increase in net cash used in investing activities was primarily due to greater investment in short-term securities during the year ended December 31, 2023.

For the year ended December 31, 2023, net cash provided by financing activities was $72.7 million as compared to net cash used in financing activities of $0.4 million for the year ended December 31, 2022.

The increase in net cash provided by financing activities was primarily attributable to proceeds from debt financings and net proceeds from the issuance of common stock as part of our ATM program that took place during the year ended December 31, 2022.

On September 5, 2019, we filed an automatic “shelf registration” statement on Form S-3 (the 2019 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 2019 WKSI Shelf was declared effective in September 2019.

In connection with the 2019 WKSI Shelf, we entered into an At-the-Market Issuance Sales Agreement (the 2020 ATM) with Jefferies LLC, Cantor Fitzgerald & Co.

Riley Securities, Inc.

(each a 2020 Agent and collectively, the 2020 Agents), relating to the sale of shares of our common stock.

Under the 2020 ATM, we paid the 2020 Agents a commission rate of up to 3.0% of the gross proceeds from the sale of any shares of common stock.

In November 2020, we entered into an At-the-Market Issuance Sales Agreement (the 2021 ATM) with the same terms and agents (each a 2021 Agent and collectively, the 2021 Agents) as the 2020 ATM.

During the year ended December 31, 2021, we sold a total of 72,000 shares of common stock under the 2021 ATM for aggregate total gross proceeds of approximately $2.5 million at an average selling price of $34.25 per share, resulting in net proceeds of approximately $2.4 million after deducting commissions and other transactions costs.

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.

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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 has replaced the 2021 ATM as the only active ATM program.

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.

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Debt Financings

On February 28, 2019 (the Closing Date), we entered into a term loan facility of up to $60.0 million (Term Loan) with Hercules Capital, Inc.

(Hercules), the proceeds of which were used for research and development programs and for general corporate purposes.

The Term Loan is governed by a loan and security agreement, dated February 28, 2019 (the Loan Agreement), which provides for up to four separate advances.

The first advance of $30.0 million was drawn on the Closing Date.

An additional $30.0 million was available with different milestones and time points that have lapsed.

On December 30, 2021 (the First Amendment Closing Date), the Company entered into an Amended and Restated Loan and Security Agreement (the Amended Loan Agreement) with Hercules Capital, Inc.

The Amended Loan Agreement amended the terms of the Loan Agreement to, among other things, (i) increase the aggregate principal amount of the loan, available at the Company’s option, from $60.0 million to $200.0 million (the Amended Term Loan), (ii) issue a first advance of $70.0 million drawn at the First Amendment Closing Date, a portion of which was used to refinance the current outstanding loan balance of approximately $7.8 million and pay for expenses incurred by the Lender in executing the agreements, (iii) change the draw amounts and dates available in Tranche 2 through Tranche 4 including increasing the amount available under Tranche 2 subject to the achievement of performance milestones from $10.0 million to $20.0 million, increasing the amount available under Tranche 3 subject to the achievement of performance milestones from $10.0 million to $45.0 million, and increasing the amount under Tranche 4 subject to the approval of Hercules’ investment committee from $10.0 million to $65.0 million, (iv) extend the maturity date of the facility from the original March 1, 2022 to January 1, 2026, (v) reset and extend the interest only period from April 1, 2021 to February 1, 2025 and extendable to August 1, 2025 subject to the achievement of certain performance milestones, and (vi) modify the cash interest rate to be the greater of either (a) the “prime rate” as reported in The Wall Street Journal plus 2.15%, and (b) 5.40%.

The performance milestones are based on achievement of certain U.S.

Food and Drug Administration approvals and impact the potential extension of the interest only period, access to future advances under the Loan Agreement and minimum cash levels required under the Amended Loan Agreement.

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.

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.

As of December 31, 2023, we are in compliance with all financial covenants.

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

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

In addition, the Company is required to pay a final payment fee equal to 5.95% of the aggregate principal amount of the Term Loan Advances (as defined in the Amended Loan Agreement, as amended)

The Company may, at its option, prepay the Amended Term Loan in full or in part, subject to a prepayment penalty equal to (i) 1.5% of the principal amount prepaid if the prepayment occurs prior to the first anniversary of the First Amendment Effective Date, and (ii) 1.0% of the principal amount prepaid if the prepayment occurs on or after the first anniversary of the First Amendment Effective Date.

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.

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 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 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.

At December 31, 2024, the remaining unamortized balance of debt issuance and debt discount costs was $5.6 million.

In October 2014, we entered into an agreement (the Office Agreement) with Fortress Biotech, Inc.

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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 condensed consolidated balance sheets.

Total rental expense was approximately $2.3 million, $2.2 million and $2.7 million for the years ended December 31, 2024, 2023 and 2022, respectively.

Future minimum lease commitments as of December 31, 2024 total, in the aggregate, approximately $12.6 million through December 31, 2032.

Our future minimum lease commitments include our office leases in New York, New Jersey and North Carolina as of December 31, 2023.

Our future minimum lease commitments include our office leases in New York and North Carolina as of December 31, 2024.

OFF-BALANCE SHEET ARRANGEMENTS

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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 and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns.

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.

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Stock Compensation .

We have granted stock options and restricted stock to employees, directors and consultants, as well as warrants to other third parties.

For employee, director and consultant grants the value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model.

The Black-Scholes model takes into account volatility in the price of our stock, the risk-free interest rate, the estimated life of the option, the closing market price of our stock and the exercise price.

We base our estimates of our stock price volatility on the historical volatility of our common stock and our assessment of future volatility;

however, these estimates are neither predictive nor indicative of the future performance of our stock.

For purposes of the calculation, we assumed that no dividends would be paid during the life of the options and warrants.

The estimates utilized in the Black-Scholes calculation involve inherent uncertainties and the application of management judgment.

In addition, because some of the options, restricted stock and warrants issued to employees, consultants and other third parties vest upon the achievement of certain milestones, the total expense is uncertain.

Compensation expense for such awards that vest upon the achievement of milestones is recognized when the achievement of such milestones becomes probable.

Stock-based compensation costs related to equity awards granted to employees and non-employees are measured at the date of grant based on the fair value of the award.

We estimate the grant date fair value of options, and the resulting stock-based compensation expense, using the Black-Scholes option-pricing model.

Equity awards with market conditions are valued using advanced option-pricing models, such as a Monte Carlo simulation.

The effect of a market condition is reflected in the award’s fair value on the grant date.

For time-based or performance-based restricted stock, the fair value is based on the market value of our common stock on the date of grant.

Stock-based compensation expense for time-based restricted stock and options is recognized on a straight-line basis over the requisite service period.

Stock-based compensation expense for awards that vest upon the achievement of milestones is recognized over the requisite service period when the achievement of such milestones becomes probable.

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.

Accrued Research and Development Expenses.

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RECENTLY ISSUED ACCOUNTING STANDARDS

Management does not believe that any recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material effect on the Company’s financial statements.

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 .

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