TG Therapeutics, Inc.

    TGTX ·NASDAQ ·Pharmaceutical Preparations ·Inc. in DE
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    ITEM 1. BUSINESS.

     

    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.

     

    Business Highlights

     

    Next In MS Platform Launch in Collaboration with Christina Applegate

     

    Announced collaboration with Christina Applegate to raise awareness of multiple sclerosis (MS) via a Super Bowl LX commercial

    Launched, Next In MS™, a platform designed to foster honest, real-world conversations about life with MS—featuring unfiltered dialogue, including discussions with Christina Applegate—and to support people living with MS in continuing those conversations with family, friends, and healthcare professionals on their own terms.

     

    Commercialization 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 by the FDA in December 2022 for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, based on data from the ULTIMATE I & II Phase 3 trials, which demonstrated superiority over teriflunomide in significantly reducing the annualized relapse rate (ARR, the primary endpoint), the number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions. Results from the ULTIMATE I & II trials were published in August 2022 in The New England Journal of Medicine. We commercially launched BRIUMVI in the U.S. in January 2023, making it available to physicians and patients.

     

    In August 2023, we entered into a commercialization agreement (the Commercialization Agreement) with Neuraxpharm Pharmaceuticals, S.L. (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, for the ex-U.S. commercialization of BRIUMVI. In February 2024, BRIUMVI was first made available in the European market by Neuraxpharm in Germany and is now commercially available in several other countries outside of the U.S.

     

    Pipeline Development

     

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

     

    In August 2025, we announced the first patient with progressive multiple sclerosis has been dosed with azer-cel in a Phase 1 trial.

     

    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 February 2026, we announced that the Phase 3 trial was more than approximately 75% enrolled. 

     

    In October 2025, we announced completion of enrollment in the randomized cohort of the Phase 3 ENHANCE trial evaluating a consolidated day 1 and day 15 dosing schedule for IV BRIUMVI® in people with RMS. The primary endpoint of this trial is non inferior exposure with respect to area under the curve (AUC) at week 16.

     

    Share Repurchase Program

     

    In September 2025, we announced the completion of our previously authorized $100 million share repurchase program, which was initially announced in August 2024 (the Prior Share Repurchase Program). Under the Prior Share Repurchase Program, we repurchased a total of 3,502,334 shares of our common stock at an average price of $28.55 per share. In September 2025, the Board authorized and approved a new share repurchase program (the 2025 Share Repurchase Program) for up to $100 million of the currently outstanding shares of our common stock. There were no repurchases under the 2025 Share Repurchase Program during the three and twelve months ended December 31, 2025.

     

     ​

    CORPORATE INFORMATION

     

    We were incorporated in Delaware in 1993. Our executive offices are located at 3020 Carrington Mill Blvd, Suite 475, Morrisville, North Carolina, 27560. Our telephone number is 1-877-575-TGTX(8489), and our e-mail address is [email protected].

     

    We maintain a corporate website with the address www.tgtherapeutics.com, a website with the address www.NextinMS, and various social media accounts, including but not limited to X (formerly Twitter) and LinkedIn. We also maintain websites related to BRIUMVI, including but not limited to www.BRIUMVI.com, and www.BRIUMVIPATIENTSUPPORT.com. We make available free of charge through our corporate website our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, as well as any amendments to these reports, as soon as reasonably practicable after we electronically file such material with, or furnish such material to, the SEC. We are not including the information on our website or our social media accounts as a part of, nor incorporating either by reference into, this report. The SEC maintains a website that contains annual, quarterly, and current reports, proxy statements, and other information that issuers (including us) file electronically with the SEC. The SEC’s website address is http://www.sec.gov.

     

    In addition, we intend to use our corporate website, SEC filings, press releases, public conference calls and webcasts as well as social media to communicate with our subscribers and the public. It is possible that the information we post on social media could be deemed to be material information. Therefore, in light of the SEC’s guidance, we encourage investors, the media and others interested in us to also review the information we post on the social media channels listed on our website.

     

    STRATEGY

     

    As a fully-integrated, commercial stage biotechnology company focused on the acquisition, development and commercialization of novel treatments for B cell mediated diseases, our key corporate objectives include:

     

    Successfully commercializing BRIUMVI in the U.S. for RMS and submitting for FDA approval a simplified dosing schedule for IV BRIUMVI in the U.S.;

    Building upon the BRIUMVI approval to evaluate other uses for BRIUMVI in additional MS indications and/or other autoimmune diseases;

    Developing and seeking FDA approval of subcutaneous form of BRIUMVI (ublituximab); 

    Identifying additional areas to expand the use of BRIUMVI beyond MS;

    Continuing to expand our pipeline with mechanisms of importance to B-cell mediated diseases;

    Evaluating the potential of azer-cel to treat patients with B-cell mediated diseases, including progressive forms of multiple sclerosis; and

    Maintaining our “patient first” culture as we grow our business.

     ​

    Our Approach and Platform

     ​

    Our approach to drug development is centered on developing therapies for B-cell mediated diseases. Our process begins by identifying validated targets against B-cell mediated diseases, and then searching for and, ideally, acquiring what we believe to be “best-in-class” compounds with complementary mechanisms against these targets.

     

    Our preference is to identify targets for which there is human clinical proof of concept that the mechanism is active in B-cell mediated diseases and then to identify drug candidates that effectively modulate the desired molecular target. We identify these drug candidates at academic centers of excellence or in development at biotech companies or pharmaceutical companies globally. Our current drug candidates were acquired through license agreements, collaborations, or joint ventures with biopharmaceutical companies located globally. This approach enables us to minimize target risk while looking for the best available drug candidates around the world. By focusing on B-cell mediated diseases and targets with a known activity profile, we believe that we can quickly identify the patients most likely to respond, resulting in a more efficient development path with the potential for a greater likelihood of success.

     

    Our approach is enabled by our clinical development platform which includes an internal team with a deep understanding of B-cell mediated diseases and significant experience successfully obtaining FDA approval for innovative treatments for these complex diseases.

     ​

    AUTOIMMUNE DISEASE OVERVIEW

     

    An autoimmune disease occurs when the body’s immune system attacks and destroys healthy body tissue by mistake. There are currently more than 80 types of autoimmune disorders that have been identified. Some of these diseases may result from inappropriate production of antibodies from the B-cells. These antibodies cannot discriminate “self” from “non-self,” and inadvertently mount a disabling immune response against normal organs. Some of these diseases may not be antibody mediated but may still result from aberrant activity of B-cells. Examples of common and very debilitating autoimmune disorders for which abnormally functioning B-cells have been implicated include multiple sclerosis (MS) and rheumatoid arthritis (RA).

     

    ​The Company’s primary focus is on MS.

     

    Multiple Sclerosis Overview

     

    RMS is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of MS and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. MS is the most prevalent chronic inflammatory disease of the CNS. It is estimated that nearly 1 million people are living with MS in the United States and over 2.3 million people world-wide are living with MS.

     ​​

     

     

    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 status for our lead drug candidates as of February 2026. 

     

    Clinical Drug Candidate: (molecular target)

    Initial Target Disease

    Stage 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

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    Financial statements

    data from SEC XBRL filings. Values are as-reported; restatements supersede originals. Values reported in .

    From 10-Q filed 2026-05-06 (period ending 2026-03-31).

     2. MANAGEMENTS 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

     ​

     

    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 (p<0.005 in each study) with BRIUMVI demonstrating an ARR of <0.10 in each of the studies. Relative reductions of approximately 60% and 50% in ARR over teriflunomide were observed in ULTIMATE I & II, respectively. Key secondary MRI endpoints were also met.

    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.

     

     

    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 several B-cell cancers and autoimmune diseases. Azer-cel is designed to minimize graft-versus-host disease (GvHD), a significant complication associated with other donor-derived, cell-based therapies. In August 2024, we announced FDA clearance of the IND for azer-cel for the treatment of progressive forms of MS. In August 2025, we announced the first patient with progressive multiple sclerosis has been dosed with azer-cel in a Phase 1 trial.

     

    For more information, please refer to our Annual Report on Form 10-K for the quarter and year ended December 31, 2025.

     

     

    PIPELINE AND LIFECYCLE MANAGEMENT

     

    In addition to the ongoing commercialization of BRIUMVI, we continue to invest in our commercial organization, infrastructure, and internal capabilities to support lifecycle management and potential expansion of the product’s clinical and commercial profile. A key area of focus is the development of a subcutaneous formulation of ublituximab, which is being evaluated as a potential alternative route of administration that may offer increased convenience and flexibility for patients and healthcare providers. We are also exploring the use of BRIUMVI in autoimmune indications outside of MS and are advancing early-stage development activities for azer-cel in autoimmune diseases. These programs reflect our broader strategy to enhance the durability of our portfolio and expand future therapeutic opportunities.

     

    Beyond BRIUMVI, we continue to evaluate potential in-licensing and acquisition opportunities. These opportunities may include earlier-stage programs, complementary products, proprietary technologies, or other therapeutic approaches that could enhance our pipeline and support long-term growth. The scope, timing, and level of any such investments will depend on a range of factors, including scientific and clinical data, manufacturing feasibility, regulatory considerations, commercial readiness, available resources, and overall strategic and financial priorities. 

     

    Financial Overview and Key Components of our Operating Results

     

    Although we have recently achieved profitability, we have historically incurred substantial operating losses since our inception and may continue to experience fluctuations in operating results. Despite the commercialization of BRIUMVI and the potential future commercialization of other product candidates, there can be no assurance that we will maintain profitability on an ongoing basis.

     

    For the three months ended March 31, 2026, we generated revenue of $204.9 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 March 31, 2026, our accumulated deficit was approximately $1.1 billion, and we had $572.8 million in cash and cash equivalents, and investment securities, excluding equity investments. Based on our current operating plan and results, we anticipate that our existing cash, cash equivalents, and investment securities, together with projected future revenues, will be sufficient to fund operations and meet our liquidity needs for more than twelve months after the date of filing of this Quarterly Report on Form 10-Q.

     

    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 three months ended March 31, 2025 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 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, share-based compensation 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 salaries, benefits, travel and share-based compensation 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.

     

     

    RESULTS OF OPERATIONS

     

    The following table summarizes the results of operations for the three months ended March 31, 2026 and 2025:

     

     

    Three months ended

     
     

    March 31,

     

    (in thousands)

    2026

       

    2025

       

    Change

     

    Product revenue, net

    $ 201,308       119,655       81,653  

    License, milestone, royalty and other revenue

      3,610       1,201       2,409  

    Total Revenue

    $ 204,918     $ 120,856     $ 84,062  

    Costs and expenses:

                         

    Cost of revenue

      33,510       15,541       17,969  

    Research and development:

                         

    Stock-based compensation

      4,875       3,331       1,544  

    Other research and development

      43,521       43,031       490  

    Total research and development

      48,396       46,362       2,034  

    General and administrative:

                         

    Stock-based compensation

      15,075       11,640       3,435  

    Other selling, general and administrative

      73,142       38,691       34,451  

    Total general and administrative

      88,217       50,331       37,886  

    Total costs and expenses

      170,123       112,234       57,889  

    Interest expense

      7,666       6,757       909  

    Loss on extinguishment of debt

      9,153             9,153  

    Other income

      (2,387 )     (3,603 )     1,216  

    Total other expense

      14,432       3,154       11,278  

    Net income before taxes

      20,363       5,468       14,895  

    Income tax expense

      (586 )     (408 )     (178 )

    Net income

    $ 19,777     $ 5,060     $ 14,717  

     

    Product Revenue, Net. Product revenue, net was approximately $201.3 million for the three months ended March 31, 2026, compared to $119.7 million for the three months ended March 31, 2025. Product revenue, net for both the three months ended March 31, 2026 and March 31, 2025 consisted of net product sales of BRIUMVI in the United States of $194.8 million and $119.7 million, respectively. Also included in product revenue, net for the three months ended March 31, 2026 is sales of BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, of $6.5 million. The increase in product revenue, net is a result of greater market penetration of BRIUMVI in the United States and from commercial product sales supplied to Neuraxpharm under the Commercialization Agreement.

     

    License, Milestone, Royalty and Other Revenue. License, milestone, royalty and other revenue was $3.6 million for the three months ended March 31, 2026 and $1.2 million for the three months ended March 31, 2025. License, milestone, royalty and other revenue for the three months ended March 31, 2026 is comprised of  $2.7 million of royalty revenue recognized under the Commercialization Agreement with Neuraxpharm and $0.9 million of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement (see Note 2 – Revenue for more information).

     

     

    Cost of Revenue. Cost of revenue for the three months ended March 31, 2026 was $33.5 million compared to approximately $15.5 million for the three months ended March 31, 2025. Cost of revenue for both the three months ended March 31, 2026 and March 31, 2025 consists primarily of royalties owed to our licensing partner for BRIUMVI sales, third-party manufacturing, distribution and overhead costs. A portion of the manufacturing costs of BRIUMVI sold during the quarter ending March 31, 2025 was expensed as research and development prior to the FDA approval of BRIUMVI and therefore it is not reflected in the cost of revenue. We depleted these inventories during the quarter ending March 31, 2025.

     

    Stock-Based Compensation Expense (Research and Development). Stock-based compensation expense (research and development) related to equity incentive grants and liability-classified awards totaled $4.9 million for the three months ended March 31, 2026, as compared to $3.3 million during the comparable period ended March 31, 2025. The modest increase in stock-based compensation expense was primarily due to an increase in headcount and higher grant-date stock price at which awards were granted during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025.

     

    Other Research and Development ExpenseOther research and development expense was $43.5 million for the three months ended March 31, 2026, as compared to $43.0 million during the three months ended March 31, 2025. The increase in research and development expense during the three months ended March 31, 2026 was primarily attributable to license and milestone expense in connection with the Precision License Agreement, as well as increased clinical trial related expenses pertaining to our clinical pipeline, and increased personnel costs during the period ended March 31, 2026. These increases were partially offset by lower manufacturing and development costs, in connection with our subcutaneous ublituximab development work incurred during the period ended March 31, 2026.

     

    Stock-Based Compensation Expense (Selling, General and Administrative). Stock-based compensation expense (selling, general and administrative) related to equity incentive grants and liability-classified awards totaled $15.1 million for the three months ended March 31, 2026, as compared to $11.7 million during the comparable period ended March 31, 2025. The increase in stock-based compensation expense was due to greater recognition of stock-based compensation expense for performance and market-based awards, an increase in headcount, and higher stock prices associated with awards granted during the three months ended March 31, 2026.

     

    Other Selling, General and Administrative Expenses. Other selling, general and administrative expenses totaled $73.1 million for the three months ended March 31, 2026, as compared to $38.7 million during the comparable period ended March 31, 2025. The increase was primarily due to marketing and media spend, and personnel-related costs associated with the commercialization of BRIUMVI during the three months ended March 31, 2026.

     

    Interest Expense. Interest expense totaled $7.7 million for the three months ended March 31, 2026, as compared to $6.8 million for the three months ended March 31, 2025. The increase is mainly due to increased interest expense pertaining to the First Amendment to the Financing Agreement with Blue Owl Capital during the three months ended March 31, 2026 (see Note 7 – Loan Payable for more information).

     

    Loss on extinguishment of debt. Loss on extinguishment of debt totaled $9.2 million for the three months ended March 31, 2026 related to the write-off of unamortized deferred financing and debt discount costs, as well as prepayment fees associated with the Initial Term Loan with Blue Owl Capital, as compared to zero for the three months ended March 31, 2025 (see Note 7 – Loan Payable for more information).

     

    Other Income. Other income totaled $2.4 million for the three months ended March 31, 2026, as compared to $3.6 million during the comparable period ended March 31, 2025. The decrease is mainly due to less income earned from investments during the three months ended March 31, 2026.

     

    Income Tax Expense. Income tax expense totaled $0.6 million for the three months ended March 31, 2026, as compared to Income tax expense of ($0.4) million during the comparable period ended March 31, 2025. The increase in income tax benefit is driven by the release of our deferred tax asset valuation allowance during the quarter ended September 30, 2025 and higher pre-tax income for the three months ended March 31, 2026.

     

     

    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 Capital or other financing sources.

     

    As of March 31, 2026, 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 accordance with our Financing Agreement with Blue Owl Capital, we are obligated to make interest and future principal payments.

     

    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 date of filing of this Quarterly Report on Form 10-Q. 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 three months ended March 31, 2026 and 2025:

     

     

    Three months ended

     
     

    March 31,

     

    (in thousands)

    2026

       

    2025

     

    Net cash used in operating activities

    $ (17,894 )   $ (28,715 )

    Net cash used in investing activities

    $ (9,864 )   $ (12,934 )

    Net cash provided by (used in) financing activities

    $ 390,829     $ (6,102 )

     

    Net cash used in operating activities for the three months ended March 31, 2026 was $17.9 million as compared to cash used in operating activities of $28.7 million for the three months ended March 31, 2025, representing $10.8 million improvement year over year.

     

    The improvement was driven by higher net income for the three months ended March 31, 2026, $19.8 million compared to $5.1 million for the three months ended March 31, 2025. Operating cash flow benefited from favorable working capital changes, including a decrease in inventory purchases, a $33.0 million year-over-year improvement. These favorable impacts were partially offset by an increase in accounts receivable and other current assets in three months ended March 31, 2026 and 2025, which reduced operating cash flow year over year, and a decrease in accounts payable and accrued expenses, a $31.2 million reduction.

     

    Net cash used in investing activities for the three months ended March 31, 2026 was $9.9 million as compared to $12.9  million used in investing activities for the three months ended March 31, 2025. The improvement in net cash used in investing activities was primarily due to decreased investments in held-to-maturity securities during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025.

     

     

    Net cash provided by financing activities for the three months ended March 31, 2026 was approximately $390.8 million as compared to net cash used in financing activities of $6.1 million for the three months ended March 31, 2025. Net cash provided by financing activities during the three months ended March 31, 2026 was mainly due to the proceeds from the 2026 Term Loan, net of financing costs paid, partially offset by the repurchase of stock under our share repurchase program. Net cash used in financing activities during the three months ended March 31, 2025 was mainly due to the repurchase of stock under our share repurchase program.

     

    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 ACCOUNTING ESTIMATES

     

    A critical accounting policy is one that is both important to the portrayal of our financial condition and results of operation and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. For a description of our significant accounting policies, refer to “Part II, Item 8. Financial Statements and Supplementary Data, Note 1 – Organization and Summary of Significant Accounting Policies” in our Annual Report on Form 10-K for the year ended December 31, 2025, and refer to Note 1 - Organization and Summary of Significant Accounting Policies in this Quarterly Report on Form 10-Q for significant accounting policies due to commercialization for revenue recognition, gross-to-net sales adjustments, accounts receivable, inventory, deferred tax asset valuation allowance, and cost of revenue. Of these policies, the following are considered critical to an understanding of our condensed consolidated financial statements as they require the application of the most difficult, subjective and complex judgments: revenue recognition and stock-based compensation expenses. Refer to Note 2 – Revenue and Note 6 – Stockholders’ Equity respectively, in this Quarterly Report on Form 10-Q for more information.

     

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