# TG THERAPEUTICS, INC. (TGTX)

Informational only - not investment advice.

CIK: 0001001316
SIC: 2834 Pharmaceutical Preparations
SIC breadcrumb: [Manufacturing](/division/D/) > [Chemicals And Allied Products](/major-group/28/) > [SIC 2834 Pharmaceutical Preparations](/industry/2834/)
Latest 10-K filed: 2026-02-27
SEC page: https://www.sec.gov/edgar/browse/?CIK=1001316
Filing source: https://www.sec.gov/Archives/edgar/data/1001316/000143774926006133/tgtx20251231_10k.htm

## Selected Fundamentals
| Metric | Value | Unit | FY | Filed |
| --- | ---: | --- | ---: | --- |
| Revenue | 616287000 | USD | 2025 | 2026-02-27 |
| Net income | 447179000 | USD | 2025 | 2026-02-27 |
| Assets | 1063253000 | USD | 2025 | 2026-02-27 |

## Financials

Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-02-27. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001001316.json. Derived margins are computed from the extracted annual SEC facts.

| Metric | 2011 | 2012 | 2013 | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Revenue |  |  |  |  |  |  |  |  | 6,689,000 | 2,785,000 | 233,662,000 | 329,004,000 | 616,287,000 |
| Net income | -853,074 | -18,072,719 | -20,478,210 |  |  |  |  |  | -348,101,000 | -223,812,000 | 12,672,000 | 23,383,000 | 447,179,000 |
| Operating income |  |  |  | -78,969,000 | -118,712,000 | -174,400,000 | -169,055,000 | -273,594,000 | -344,770,000 | -218,316,000 | 20,633,000 | 41,929,000 | 123,324,000 |
| Diluted EPS |  |  |  |  |  |  |  | -2.42 | -2.63 | -1.65 | 0.09 | 0.15 | 2.77 |
| Assets |  |  |  | 54,781,547 | 97,381,000 | 83,616,000 | 163,014,000 | 625,642,000 | 379,629,000 | 193,572,000 | 329,587,000 | 577,690,000 | 1,063,253,000 |
| Liabilities |  |  |  | 18,913,745 | 30,388,000 | 59,580,000 | 124,399,000 | 106,292,000 | 142,476,000 | 134,985,000 | 169,085,000 | 355,326,000 | 415,233,000 |
| Stockholders' equity | 9,624,521 | 15,550,301 |  |  |  |  |  | 519,350,000 | 237,153,000 | 58,587,000 | 160,502,000 | 222,364,000 | 648,020,000 |
| Cash and cash equivalents |  |  |  | 25,031,000 | 56,718,000 | 41,958,000 | 112,637,000 | 553,439,000 | 298,887,000 | 102,304,000 | 92,933,000 | 179,894,000 | 79,148,000 |
| Net margin |  |  |  |  |  |  |  |  |  |  | 5.42% | 7.11% | 72.56% |
| Operating margin |  |  |  |  |  |  |  |  |  |  | 8.83% | 12.74% | 20.01% |

## Quarterly

Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-05-06. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001001316.json.

Flow metrics use discrete quarter-length periods from 10-Q/10-Q/A filings. Q4 revenue and net income are derived only when annual FY and nine-month YTD facts exist for the same fiscal year; derived Q4 values are labeled. EPS Q4 is not derived.

| Quarter | End date | Revenue | Net income | Diluted EPS | Method |
| --- | --- | ---: | ---: | ---: | --- |
| 2014-Q1 | 2014-03-31 |  | -7,547,249 |  | reported discrete quarter |
| 2022-Q1 | 2022-03-31 |  |  | -0.51 | reported discrete quarter |
| 2022-Q2 | 2022-06-30 |  |  | -0.30 | reported discrete quarter |
| 2022-Q3 | 2022-09-30 |  |  | -0.26 | reported discrete quarter |
| 2023-Q1 | 2023-03-31 |  |  | -0.28 | reported discrete quarter |
| 2023-Q2 | 2023-06-30 | 16,074,000 |  | -0.34 | reported discrete quarter |
| 2023-Q3 | 2023-06-30 |  | -47,610,000 |  | reported discrete quarter |
| 2023-Q3 | 2023-09-30 | 165,815,000 |  | 0.73 | reported discrete quarter |
| 2023-Q4 | 2023-12-31 | 43,971,000 | -14,416,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2024-Q1 | 2024-03-31 | 63,474,000 | -10,707,000 |  | reported discrete quarter |
| 2024-Q2 | 2024-03-31 |  | -10,707,000 |  | reported discrete quarter |
| 2024-Q3 | 2024-06-30 |  | 6,879,000 |  | reported discrete quarter |
| 2024-Q2 | 2024-06-30 | 73,466,000 |  | 0.04 | reported discrete quarter |
| 2024-Q3 | 2024-09-30 | 83,879,000 |  | 0.02 | reported discrete quarter |
| 2024-Q4 | 2024-12-31 | 108,185,000 | 23,331,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2025-Q1 | 2025-03-31 | 120,856,000 | 5,060,000 | 0.03 | reported discrete quarter |
| 2025-Q2 | 2025-03-31 |  | 5,060,000 |  | reported discrete quarter |
| 2025-Q3 | 2025-06-30 |  | 28,187,000 |  | reported discrete quarter |
| 2025-Q2 | 2025-06-30 | 141,148,000 |  | 0.17 | reported discrete quarter |
| 2025-Q3 | 2025-09-30 | 161,709,000 |  | 2.43 | reported discrete quarter |
| 2025-Q4 | 2025-12-31 | 192,574,000 | 23,037,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2026-Q1 | 2026-03-31 | 204,918,000 | 19,777,000 | 0.12 | reported discrete quarter |

## Macro Cross-References
- [CPIAUCSL](/indicator/CPIAUCSL/): Consumer Price Index for All Urban Consumers: All Items in U.S. City Average
- [UNRATE](/indicator/UNRATE/): Unemployment Rate
- [FEDFUNDS](/indicator/FEDFUNDS/): Federal Funds Effective Rate
- [CES0500000003](/indicator/CES0500000003/): Average Hourly Earnings of All Employees, Total Private
- [DFEDTARU](/indicator/DFEDTARU/): Federal Funds Target Range - Upper Limit
- [DFEDTARL](/indicator/DFEDTARL/): Federal Funds Target Range - Lower Limit
- [DGS3MO](/indicator/DGS3MO/): Market Yield on U.S. Treasury Securities at 3-Month Constant Maturity
- [DGS2](/indicator/DGS2/): Market Yield on U.S. Treasury Securities at 2-Year Constant Maturity
- [DGS10](/indicator/DGS10/): Market Yield on U.S. Treasury Securities at 10-Year Constant Maturity
- [DGS30](/indicator/DGS30/): Market Yield on U.S. Treasury Securities at 30-Year Constant Maturity
- [T10Y2Y](/indicator/T10Y2Y/): 10-Year Treasury Constant Maturity Minus 2-Year Treasury Constant Maturity
- [CPILFESL](/indicator/CPILFESL/): Consumer Price Index for All Urban Consumers: All Items Less Food and Energy
- [CPIUFDSL](/indicator/CPIUFDSL/): Consumer Price Index for All Urban Consumers: Food
- [CPIENGSL](/indicator/CPIENGSL/): Consumer Price Index for All Urban Consumers: Energy
- [CUSR0000SAH1](/indicator/CUSR0000SAH1/): Consumer Price Index for All Urban Consumers: Shelter
- [PCEPI](/indicator/PCEPI/): Personal Consumption Expenditures: Chain-type Price Index
- [PCEPILFE](/indicator/PCEPILFE/): Personal Consumption Expenditures Excluding Food and Energy: Chain-type Price Index
- [PPIACO](/indicator/PPIACO/): Producer Price Index by Commodity: All Commodities
- [T10YIE](/indicator/T10YIE/): 10-Year Breakeven Inflation Rate
- [U6RATE](/indicator/U6RATE/): Total Unemployed, Plus All Marginally Attached Workers Plus Total Employed Part Time for Economic Reasons
- [PAYEMS](/indicator/PAYEMS/): All Employees, Total Nonfarm
- [CIVPART](/indicator/CIVPART/): Labor Force Participation Rate
- [EMRATIO](/indicator/EMRATIO/): Employment-Population Ratio
- [UNEMPLOY](/indicator/UNEMPLOY/): Unemployed
- [CE16OV](/indicator/CE16OV/): Employment Level
- [ICSA](/indicator/ICSA/): Initial Claims
- [JTSJOL](/indicator/JTSJOL/): Job Openings: Total Nonfarm
- [JTSQUR](/indicator/JTSQUR/): Quits: Total Nonfarm
- [GDPC1](/indicator/GDPC1/): Real Gross Domestic Product
- [A191RL1Q225SBEA](/indicator/A191RL1Q225SBEA/): Real Gross Domestic Product: Percent Change from Preceding Period
- [INDPRO](/indicator/INDPRO/): Industrial Production: Total Index
- [TCU](/indicator/TCU/): Capacity Utilization: Total Index
- [HOUST](/indicator/HOUST/): New Privately-Owned Housing Units Started: Total Units
- [PERMIT](/indicator/PERMIT/): New Privately-Owned Housing Units Authorized in Permit-Issuing Places: Total Units
- [RSAFS](/indicator/RSAFS/): Advance Retail Sales: Retail Trade
- [PCE](/indicator/PCE/): Personal Consumption Expenditures
- [DSPIC96](/indicator/DSPIC96/): Real Disposable Personal Income
- [PSAVERT](/indicator/PSAVERT/): Personal Saving Rate
- [M2SL](/indicator/M2SL/): M2
- [BOPGSTB](/indicator/BOPGSTB/): U.S. International Trade in Goods and Services: Balance
- [MSPUS](/indicator/MSPUS/): Median Sales Price of Houses Sold for the United States
- [HSN1F](/indicator/HSN1F/): New One Family Houses Sold: United States
- [RHORUSQ156N](/indicator/RHORUSQ156N/): Homeownership Rate in the United States
- [TTLCONS](/indicator/TTLCONS/): Total Construction Spending: Total Construction in the United States
- [RRVRUSQ156N](/indicator/RRVRUSQ156N/): Rental Vacancy Rate in the United States
- [TOTALSL](/indicator/TOTALSL/): Total Consumer Credit Owned and Securitized
- [REVOLSL](/indicator/REVOLSL/): Revolving Consumer Credit Owned and Securitized
- [DRCCLACBS](/indicator/DRCCLACBS/): Delinquency Rate on Credit Card Loans, All Commercial Banks
- [GDP](/indicator/GDP/): Gross Domestic Product
- [GPDI](/indicator/GPDI/): Gross Private Domestic Investment
- [GCE](/indicator/GCE/): Government Consumption Expenditures and Gross Investment
- [PCEC](/indicator/PCEC/): Personal Consumption Expenditures
- [NETEXP](/indicator/NETEXP/): Net Exports of Goods and Services
- [GFDEBTN](/indicator/GFDEBTN/): Federal Debt: Total Public Debt
- [GFDEGDQ188S](/indicator/GFDEGDQ188S/): Federal Debt: Total Public Debt as Percent of Gross Domestic Product
- [FYFSD](/indicator/FYFSD/): Federal Surplus or Deficit
- [FGRECPT](/indicator/FGRECPT/): Federal Government Current Receipts
- [FGEXPND](/indicator/FGEXPND/): Federal Government: Current Expenditures
- [MANEMP](/indicator/MANEMP/): All Employees, Manufacturing
- [USCONS](/indicator/USCONS/): All Employees, Construction
- [USTRADE](/indicator/USTRADE/): All Employees, Retail Trade
- [USFIRE](/indicator/USFIRE/): All Employees, Financial Activities
- [USGOVT](/indicator/USGOVT/): All Employees, Government
- [AWHAETP](/indicator/AWHAETP/): Average Weekly Hours of All Employees, Total Private
- [DGORDER](/indicator/DGORDER/): Manufacturers' New Orders: Durable Goods
- [NEWORDER](/indicator/NEWORDER/): Manufacturers' New Orders: Nondefense Capital Goods Excluding Aircraft
- [BUSINV](/indicator/BUSINV/): Total Business Inventories
- [EXPGS](/indicator/EXPGS/): Exports of Goods and Services
- [IMPGS](/indicator/IMPGS/): Imports of Goods and Services
- [IR](/indicator/IR/): Import Price Index (End Use): All Commodities
- [PPIFIS](/indicator/PPIFIS/): Producer Price Index by Commodity: Final Demand

## Latest quarter (10-Q)

Latest 10-Q source: https://www.sec.gov/Archives/edgar/data/1001316/000143774926015246/tgtx20260331_10q.htm

Extracted between Part I Item 2 and the next Item 3/4 or Part II heading after HTML sanitization.
Confidence: high
Filing date: 2026-05-06
Report date: 2026-03-31

ITEM 2. 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. 

You should read the following discussion and analysis in conjunction with the condensed consolidated financial statements and the related footnotes thereto appearing elsewhere in this report, and in conjunction with management’s discussion and analysis and the audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2025. 

OVERVIEW 

TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI (ublituximab-xiiy) to treat adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval from several regulatory agencies outside of the U.S. for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities.

RECENT EVENTS

Subcutaneous BRIUMVI

In April 2026, we announced the Phase 3 trial evaluating subcutaneous BRIUMVI completed enrollment and topline data is expected around year-end 2026 or first quarter 2027.  

Financial Update

In March 2026, we entered into a new five-year, $750 million senior secured credit facility with funds managed by Blue Owl Capital. As part of the transaction, we repaid our outstanding $250 million senior secured credit facility, resulting in a net raise of $500 million in non-dilutive capital. The new facility also provides for up to an additional $250 million of incremental capital, for a total facility size of up to $1 billion, available at the mutual discretion of TG and Blue Owl Capital. In connection with the new facility, our Board of Directors authorized an increase to our share repurchase program from $100 million to $300 million. Since the inception of the first share repurchase program in 2024, and as of April 30, 2026, we have repurchased a total of $200 million of common stock at an average price of $29.28 per share, of which $100 million was completed during the first quarter of 2026.

OUR PRODUCTS

We currently license worldwide development and commercial rights, subject to certain limited geographical restrictions, for all of our products under development. The following table summarizes the current clinical trial status for our lead drug candidates as of March 2026. 

Clinical Drug Candidate:

(molecular target)

Initial Target Disease

Stage/Status of Development

Ublituximab IV (anti-CD20 mAb)

RMS

APPROVED

Ublituximab IV Simplified Dosing Schedule

RMS

Phase 3 completed enrollment

Ublituximab Subcutaneous (anti-CD20 mAb)

RMS

Phase 3 completed enrollment

Azer-cel

Progressive Forms of Multiple Sclerosis

Phase 1 enrolling

 ​

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BRIUMVI (ublituximab-xiiy) Overview

Development of BRIUMVI

BRIUMVI is an anti-CD20 monoclonal antibody that can be administered to adults with RMS in a one-hour infusion every 24 weeks, following the starting dose. BRIUMVI received approval from the FDA primarily based on results from the ULTIMATE I and ULTIMATE II Phase 3 trials. Each trial was an independent global, randomized, multi-center, double-blinded, double-dummy, active-controlled study comparing the efficacy and safety/tolerability of BRIUMVI (450mg dose administered by one-hour intravenous infusion every 6 months, following a day 1 infusion of 150mg over four hours and a day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with RMS.

●

In December 2020, we announced positive top-line results from the ULTIMATE I & II trials. Both studies met their primary endpoint of significantly reducing ARR over a 96-week period (p0.005 in each study) with BRIUMVI demonstrating an ARR of 0.10 in each of the studies. Relative reductions of approximately 60% and 50% in ARR over teriflunomide were observed in ULTIMATE I & II, respectively. Key secondary MRI endpoints were also met.

●

On August 22, 2022, the full results from the ULTIMATE I & II trials were published in the New England Journal of Medicine.

●

On February 27, 2024, we announced the issuance of three additional patents by the United States Patent and Trademark Office (USPTO) for BRIUMVI, which extended patent protection through 2042.

●

In August 2025, we announced patient enrollment commenced into a randomized Phase 3 pivotal cohort to evaluate a consolidated Day 1 and Day 15 dosing regimen for IV BRIUMVI in the ongoing ENHANCE Phase 3b trial, and in October 2025 we announced the trial completed enrollment.

●

In February 2026, five-year data from the ongoing open label extension (OLE) of the Phase 3 ULTIMATE I and II studies published in JAMA Neurology.

U.S. Commercialization of BRIUMVI and Market Dynamics

BRIUMVI (ublituximab-xiiy), an anti-CD20 monoclonal antibody indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, was approved by the U.S. Food and Drug Administration (FDA) in December 2022 and commercially launched in the United States in January 2023. BRIUMVI is administered as a one-hour, twice per year infusion following the starting dose. Since launch, our commercialization efforts have focused on expanding prescriber awareness, increasing penetration across infusion centers and neurology practices, securing payer coverage, and supporting patient access within a competitive RMS treatment landscape.

We believe BRIUMVI’s clinical profile, including its one-hour infusion time and twice-annual dosing schedule, together with demonstrated efficacy and safety in pivotal trials and accumulating real-world experience, supports its positioning within the anti-CD20 therapeutic class. The anti-CD20 class represents a significant segment of the RMS market, reflecting physician familiarity with the mechanism of action and long-term treatment considerations. Our ability to expand adoption is dependent on continued execution across access and site-of-care pathways; however, uptake may be influenced by factors including established prescribing practices, patient switching dynamics, payer coverage and utilization management requirements, competitive contracting, site-of-care logistics, and evolving treatment guidelines.

The RMS market is highly competitive and includes numerous approved disease-modifying therapies with varying mechanisms of action, routes of administration, safety profiles, and dosing schedules. Competitive dynamics may be influenced by pricing and contracting strategies, payer utilization management practices, the introduction of new branded products or biosimilars, and broader healthcare system and macroeconomic conditions. Our ability to continue to grow BRIUMVI revenues will depend on sustained physician adoption, patient persistence and adherence, competitive differentiation within the anti-CD20 class, and continued access across commercial and government payers.

Our net product revenue is subject to gross-to-net adjustments, including mandatory government discounts and rebates, contractual rebates and chargebacks, trade discounts and allowances (including cash discounts), product returns, distribution fees, and patient support programs. These adjustments are influenced by payer and site of care mix, coverage determinations, contracting dynamics, and patient assistance utilization, and may fluctuate from period to period. As our commercial footprint expands and payer contracting strategies evolve, the magnitude and variability of these adjustments may change.

30

Table of Contents

Ex-U.S. Commercialization of BRIUMVI

In June 2023, we announced that the EC granted approval of BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. With this approval, the centralized marketing authorization is valid in all EU member states, Iceland, Norway and Liechtenstein. 

In August 2023, we announced an agreement with Neuraxpharm Pharmaceuticals, S.L. (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of CNS disorders, for the Ex-U.S. commercialization of BRIUMVI (Commercialization Agreement). Under the terms of the Commercialization Agreement, we received an upfront payment of $140 million, and $12.5 million upon launch in the first EU country in February 2024, and up to an additional $492.5 million in milestone-based payments on achievement of certain launch and commercial milestones. The total deal is valued at up to $645 million in upfront and milestone payments. In addition, we will receive tiered double-digit royalties on net product sales up to 30%. In exchange, Neuraxpharm will have the exclusive right to commercialize BRIUMVI in territories outside the U.S., Canada and Mexico, which are retained by TG, and excluding certain Asian countries of which we previously partnered.

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

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

Subcutaneous Ublituximab Overview

In August 2024, we announced the initiation of a Phase 1 clinical trial evaluating subcutaneous ublituximab (the active ingredient in BRIUMVI), and sometimes otherwise referred to as “subcutaneous BRIUMVI" in patients with RMS. 

In January 2025, we announced the first patients with myasthenia gravis (MG) have been enrolled in a clinical trial evaluating ublituximab.

In September 2025 we announced enrollment commenced in the Phase 3 pivotal program evaluating subcutaneous ublituximab. The Phase 3 pivotal program is a randomized, open label, parallel-group, multicenter study designed to evaluate the pharmacokinetics, pharmacodynamics, safety, radiological and clinical effects of subcutaneous ublituximab compared to IV BRIUMVI in adult participants with RMS. Participants will be randomized into one of three arms: 8-week regimen of subcutaneous ublituximab, 12-week regimen of subcutaneous ublituximab or the currently approved IV BRIUMVI dosing schedule. The primary endpoint of the trial is non inferior exposure of subcutaneous ublituximab compared to IV BRIUMVI with respect to area under the curve (AUC) at week 24. In April 2026, we announced the trial completed enrollment and topline data is expected around year-end 2026 or first quarter 2027.

Azercabtagene Zapreleucel (azer-cel)

Azer-cel is an allogeneic (off-the-shelf) CD19-directed CAR T cell therapy under development by us for autoimmune diseases. Made from donor-derived T cells modified using a proprietary ARCUS genome editing technology, azer-cel recognizes the well characterized B-cell surface protein CD19, an important and validated target in sev

[Excerpt truncated for page length; source filing is linked above.]

## Latest 10-K MD&A

Extracted between Item 7 and the next Item 7A/8 heading after HTML sanitization.
Confidence: high

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

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.

56

Table of Contents

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.

Overview

TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI (ublituximab-xiiy) to treat adult patients with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval from several regulatory agencies outside of the U.S. for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. We also actively evaluate complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities.

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.

57

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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; and

●

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; and

●

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

Selling, General, and Administrative (SG&A) Expenses (Other)

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

●

Commercial operations costs, including salaries and related expenses, benefits, incentives, 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.

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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. 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. We recognize forfeitures as they occur. 

RESULTS OF OPERATIONS

Comparison of the Years Ended December 31, 2025 and 2024

The following table summarizes the results of operations for the years ended December 31, 2025 and 2024:

(in thousands)

2025

2024

Change

Product revenue, net

$

606,928

$

313,728

$

293,200

License, milestone, royalty and other revenue

9,359

15,276

(5,917

)

Total Revenue

$

616,287

$

329,004

$

287,283

Costs and expenses:

Cost of revenue

100,714

38,486

62,228

Research and development:

Noncash compensation

16,618

11,160

5,458

Other research and development

143,597

83,131

60,466

Total research and development

160,215

94,291

65,924

Selling, general and administrative:

Noncash compensation

48,053

31,381

16,672

Other selling, general and administrative

183,981

122,917

61,064

Total selling, general and administrative

232,034

154,298

77,736

Total costs and expenses

492,963

287,075

205,888

Interest expense

26,727

24,028

2,699

Other income

(10,793

)

(7,693

)

(3,100

)

Total other expense, net

15,934

16,335

(401

)

Net income before taxes

107,390

25,594

81,796

Income tax benefit (expense)

339,789

(2,211

)

342,000

Net income

$

447,179

$

23,383

$

423,796

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. 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, 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, 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 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.

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Other Research and Development Expense. 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 $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 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 $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 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

The following table summarizes the results of operations for the years ended December 31, 2024 and 2023:

(in thousands)

2024

2023

Change

Product revenue, net

$

313,728

$

92,005

$

221,723

License, milestone, royalty and other revenue

15,276

141,657

(126,381

)

Total Revenue

$

329,004

$

233,662

$

95,342

Costs and expenses:

Cost of revenue

38,486

14,131

24,355

Research and development:

Noncash compensation

11,160

13,010

(1,850

)

Other research and development

83,131

63,182

19,949

Total research and development

94,291

76,192

18,099

Selling, general and administrative:

Noncash compensation

31,381

24,923

6,458

Other selling, general and administrative

122,917

97,783

25,134

Total selling, general and administrative

154,298

122,706

31,592

Total costs and expenses

287,075

213,029

74,046

Interest expense

24,028

12,615

11,413

Other income

(7,693

)

(5,044

)

(2,649

)

Total other expense, net

16,335

7,571

8,764

Net income before taxes

25,594

13,062

12,532

Income tax expense

(2,211

)

(390

)

(1,821

)

Net income

$

23,383

$

12,672

$

10,711

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Product Revenues, net. 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.

License Revenue. 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. 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, 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 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 it is not reflected in the cost of revenue. We depleted these inventories during the quarter ended March 31, 2025. 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 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 ended in 2023. 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, 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 $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 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.

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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

The following table summarizes our cash flows for the years ended December 31, 2025 and 2024:

(in thousands)

2025

2024

Net cash used in operating activities

$

(24,772

)

$

(40,517

)

Net cash provided by (used in) investing activities

$

13,799

$

(1,036

)

Net cash (used in) provided by financing activities

$

(89,729

)

$

128,527

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.

ATM Program 

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. and B. Riley Securities, Inc. has expired. 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 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 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.

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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.

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.

Leases

In October 2014, we entered into an agreement (the Office Agreement) with Fortress Biotech, Inc. (FBIO) to occupy approximately 45% of the 24,000 square feet of New York City office space leased by FBIO. The Office Agreement requires us to pay our respective share of the average annual rent and other costs of the 15-year lease. 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.

Future minimum lease commitments as of December 31, 2025 total, in the aggregate, approximately $10.5 million through December 31, 2031. Our future minimum lease commitments include our office leases in New York and North Carolina as of December 31, 2025.

OFF-BALANCE SHEET ARRANGEMENTS

We have not entered into any transactions with unconsolidated entities whereby we have financial guarantees, subordinated retained interests, derivative instruments or other contingent arrangements that expose us to material continuing risks, contingent liabilities, or any other obligations under a variable interest in an unconsolidated entity that provides us with financing, liquidity, market risk or credit risk support.

CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES

The discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with U.S. 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 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 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. Our critical accounting policies include the following:

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

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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 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.

Stock Compensation. 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. 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. We recognize forfeitures as they occur.

Accrued Research and Development Expenses. As part of the process of preparing our financial statements, we are required to estimate our accrued expenses. This process involves reviewing open contracts, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. The majority of our service providers invoice us monthly for services performed or when contractual milestones are met. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. We periodically confirm the accuracy of our estimates with the service providers and make adjustments, if necessary. Examples of estimated accrued research and development expenses include: ​

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fees paid to contract research organizations (CROs) in connection with clinical studies;

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fees paid to contract manufacturing organizations (CMOs);

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fees paid to trial sites in connection with clinical studies; and

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fees paid to vendors associated with licenses/milestones.

We base our expenses related to clinical studies on our estimates of the services received and efforts expended pursuant to contracts with multiple CROs that conduct and manage clinical studies on our behalf. The financial terms of these agreements are subject to an initial negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing certain service fees, we estimate the time period over which services will be performed, enrollment of patients, number of sites activated and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepaid accordingly. 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

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

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