During year 6 of continuous treatment with BRIUMVI the annualized relapse rate was 0.012, equivalent to one relapse occurring every 83 years of patient treatment Overall safety profile of BRIUMVI remained consistent over 6 years of continuous treatment, with no new safety signals emerging with prolonged treatment NEW YORK, Sept. 24, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced updated data presentations including new six-year data from the ULTIMATE I & II Phase 3 trials eva ...

NEW YORK, Sept. 10, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the upcoming schedule of presentations highlighting BRIUMVI® (ublituximab-xiiy) data in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, being held September 24 - 26, 2025 in Barcelona, Spain. Abstracts are now available online and can be accessed on the ECTRIMS meeting website or at the followin ...

TG Therapeutics FY Conference Summary Company Overview - **Company**: TG Therapeutics (NasdaqCM:TGTX) - **Focus**: Development and commercialization of therapies for relapsing multiple sclerosis (MS) and other autoimmune diseases Industry Context - **Market Size**: Approximately 1 million individuals in the US have relapsing forms of MS, with 300,000 to 400,000 treated annually. About 80,000 patients seek new treatments each year [3][4] - **Treatment Landscape**: The anti-CD20 monoclonal antibody class includes three drugs, with TG Therapeutics' product, Brionvy, being one of them. The market is competitive, with a significant portion of patients switching therapies frequently [4][5] Key Points and Arguments Product Differentiation - **Administration Options**: Brionvy is administered intravenously (IV), while competitors offer both IV and subcutaneous (subcu) options. Approximately 35% to 40% of patients prefer subcu options, while 65% choose IV [6][9] - **Infusion Time**: Brionvy has a one-hour infusion time compared to competitors' two to three and a half hours, potentially offering significant time savings for patients [8][9] - **Cost Advantage**: Brionvy is priced 20% to 25% lower than its main competitor, which may influence clinician choice [9] Revenue Guidance and Market Penetration - **2025 Revenue Guidance**: Projected revenue for 2025 is between $5.70 billion and $5.75 billion, driven by new start forms and patient persistence on therapy [10][12] - **Market Share**: Brionvy is approaching a 33% market share in the IV segment, up from 25% at the beginning of the year [17][18] Patient Demographics - **Switching Patterns**: The majority of patients starting on Brionvy are switching from other therapies, not just other anti-CD20 treatments [19][20] Real-World Efficacy - **Patient Experience**: Anecdotal evidence suggests that patients on Brionvy are experiencing good outcomes, with lower rates of infusion-related reactions (IRRs) compared to competitors [21][24][25] Commercialization Strategy - **Launch Approach**: TG Therapeutics has focused on educating clinicians before direct-to-patient marketing. Recently, they launched a TV commercial to increase patient awareness [28][29] - **International Plans**: The company has partnered with Nurax Farm for ex-US commercialization, but expects US sales to dominate overall revenues [30][31] Development Pipeline - **Subcutaneous Formulation**: Enrollment for a pivotal trial for a subcu formulation has begun, with potential approval expected in 2028 [37][38] - **Other Indications**: The company is exploring the use of Brionvy in myasthenia gravis (MG) but has not committed to moving forward yet [44][46] - **CAR T Development**: TG Therapeutics is also developing a CD19 CAR T therapy, with ongoing trials in progressive MS [47][50] Upcoming Milestones - **Revenue Updates**: Anticipated revenue surprises as the company updates forecasts [54] - **Data Releases**: ENHANCE data expected in 2026, subcu data in 2027, and potential updates on the CAR T program [55][56] Additional Insights - **Market Opportunity**: The company aims to capture a significant share of the subcu market currently dominated by competitors [42][43] - **Patient Enrollment**: Expansion of protocols to include various MS types and other indications is planned [51][52]

Core Insights - TG Therapeutics has initiated a Phase 3 trial for subcutaneous BRIUMVI (ublituximab-xiiy) targeting relapsing forms of multiple sclerosis (RMS) [1][2] - The trial aims to evaluate the pharmacokinetics, safety, and clinical effects of subcutaneous BRIUMVI compared to the currently approved intravenous (IV) formulation [2][3] - If successful, subcutaneous BRIUMVI could capture a significant portion of the market, particularly the estimated 40% of RMS patients who prefer self-injectable therapies [2] Company Overview - TG Therapeutics is a biopharmaceutical company focused on developing treatments for B-cell diseases, with BRIUMVI approved for RMS in the U.S. and several other regions [27] - The company aims to provide innovative treatment options and enhance patient choice in managing RMS [2][27] Product Information - BRIUMVI is a monoclonal antibody that targets CD20-expressing B-cells, designed to efficiently deplete B-cells at low doses through glycoengineering [3] - The drug is currently administered as a one-hour IV infusion twice a year, and the new subcutaneous option aims to offer greater flexibility for patients [1][2] Clinical Trial Details - The Phase 3 trial is a non-inferiority, randomized, open-label study comparing subcutaneous BRIUMVI administered every 8 weeks and every 12 weeks against the IV regimen [2] - The primary endpoint is to demonstrate non-inferior exposure of subcutaneous BRIUMVI compared to IV BRIUMVI at week 24 [2] Market Potential - The introduction of a subcutaneous formulation could significantly broaden the market opportunity for BRIUMVI, potentially increasing its adoption among patients who prefer self-administration [2] - The company anticipates that positive trial results could support regulatory approval by 2028 [2]

Fireside chat scheduled for Monday, September 8, 2025, at 10:30am ETNEW YORK, Sept. 04, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in the H.C. Wainwright 27th Annual Global Investment Conference, being held in New York, NY on September 8 – 10, 2025. The fireside chat is scheduled to take place on Monday, September 8, 2025, at 10:30am ET. A live webcast of the fireside chat will be a ...

It has been about a month since the last earnings report for TG Therapeutics (TGTX) . Shares have added about 4.7% in that time frame, outperforming the S&P 500.Will the recent positive trend continue leading up to its next earnings release, or is TG Therapeutics due for a pullback? Well, first let's take a quick look at the latest earnings report in order to get a better handle on the recent drivers for TG Therapeutics, Inc. before we dive into how investors and analysts have reacted as of late.TG Therapeu ...

TG Therapeutics (TGTX) Conference Call Summary Company Overview - **Company**: TG Therapeutics (TGTX) - **Event**: 2025 Conference on September 03, 2025 - **Key Speaker**: Mike Weiss, Chairman and CEO Key Points Product Launch and Performance - **Bremvio Launch**: Launched approximately two and a half years ago, exceeding internal and Wall Street projections consistently each quarter and year [4][5] - **Focus on Healthcare Providers**: Initial strategy focused on educating healthcare providers about Bremvio, with a shift towards direct-to-patient programming now underway [5][6] - **Advertising Initiatives**: First commercial aired on traditional and connected TV platforms, indicating a significant push in marketing efforts [6][7] Drug Profile and Market Position - **Efficacy and Tolerability**: Bremvio demonstrated an annualized relapse rate (ARR) of 0.08 in phase three trials, with a long-term follow-up showing an ARR of one relapse in every fifty treatment years [9][10] - **Competitive Pricing**: Bremvio is priced approximately 25% lower than competitors, which is a significant factor for price-sensitive customers [11][12] - **Market Share Dynamics**: CD20 drugs hold over 50% market share, with Bremvio capturing about one in three dynamic patients in the IV class [14][18] Guidance and Financial Performance - **Conservative Guidance Philosophy**: The company maintains a conservative approach to guidance, aiming to avoid missing projections, with a current target of $575 million for the year [20][21] - **Gross to Net Dynamics**: The gross-to-net ratio is expected to range between 70% and 75%, influenced by 340B hospital utilization [29][30] Pipeline and Future Opportunities - **Subcutaneous Formulation**: The subcutaneous version of Bremvio is anticipated to represent a significant market opportunity, potentially doubling the market size for the product [58][59] - **Ezrcel Development**: Early-stage development for primary progressive MS is ongoing, with expectations for increased enrollment in 2026 [60][62] Capital Allocation and Share Buyback - **Share Buyback Authorization**: A new $100 million share buyback was announced, with $70 million already executed, indicating confidence in the company's valuation [65][68] - **Business Development Strategy**: The company is actively evaluating business development opportunities, focusing on early to mid-stage assets rather than major acquisitions [70][72] Competitive Landscape - **Impact of Ocrevus**: The CEO views the potential introduction of a biosimilar Ocrevus as an opportunity rather than a threat, expecting continued market share growth for Bremvio [43][44] Market Trends and Seasonality - **Seasonal Trends**: July showed record enrollment, while August was slower, consistent with historical trends in the MS market [24][25] Additional Insights - **Direct-to-Consumer Investments**: The company is investing in direct-to-consumer marketing, with patient awareness levels reportedly increasing [39][40] - **Long-term Market Dynamics**: The CEO expressed confidence in the long-term growth potential of Bremvio, emphasizing the importance of patient accumulation in market modeling [48][49] This summary encapsulates the key insights and strategic directions discussed during the TG Therapeutics conference call, highlighting the company's performance, market positioning, and future opportunities.

Company Overview - TG Therapeutics, Inc. has completed a $100 million share repurchase program, initially announced in August 2024, repurchasing approximately 3.5 million shares at an average price of $28.55 per share [1][3] - The Board of Directors has authorized a new share repurchase program for an additional $100 million of common stock, which may be executed through various means depending on market conditions [2] Financial Performance - In August 2025, the company repurchased about $78 million worth of stock, indicating a strategic move to enhance shareholder value [3] - The company believes that current market prices do not reflect the potential of its product BRIUMVI and its long-term growth prospects [3] Product Information - BRIUMVI (ublituximab-xiiy) is a novel monoclonal antibody targeting CD20-expressing B-cells, designed for efficient B-cell depletion at low doses [4] - It is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in the U.S. and Europe, including various specific conditions [5][24] Market Position - TG Therapeutics is focused on the acquisition, development, and commercialization of treatments for B-cell diseases, with BRIUMVI being a key product approved by regulatory agencies in multiple regions [24]

Company Overview - TG Therapeutics is a fully integrated, commercial stage biopharmaceutical company focused on the acquisition, development, and commercialization of novel treatments for B-cell diseases [3] - The company has received FDA approval for BRIUMVI (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis [3] - BRIUMVI has also been approved by regulatory agencies in Europe, the UK, Switzerland, and Australia for treating adult patients with active relapsing multiple sclerosis [3] Upcoming Events - Michael S. Weiss, the Chairman and CEO of TG Therapeutics, will participate in the Cantor Global Healthcare Conference scheduled for September 3-5, 2025 [1] - A fireside chat with Michael S. Weiss is scheduled for September 3, 2025, at 10:20 am ET [1] - A live webcast of the fireside chat will be available on the company's website [2]

[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q) This section provides foundational details of the Form 10-Q filing, including registrant identification and common stock information [Registrant Information](index=1&type=section&id=Registrant%20Information) This section provides basic identification details for TG Therapeutics, Inc. as a registrant filing a Quarterly Report on Form 10-Q, including its incorporation state and Nasdaq trading symbol - TG Therapeutics, Inc. is filing a Quarterly Report on Form 10-Q for the period ended June 30, 2025[2](index=2&type=chunk) Common Stock Trading Information | Title of Class | Trading Symbol(s) | Exchange Name | | :--------------- | :------------------ | :------------ | | Common Stock, par value $0.001 | TGTX | Nasdaq Capital Market | - The registrant is a Large Accelerated Filer and has filed all required reports and interactive data files during the preceding 12 months[4](index=4&type=chunk)[5](index=5&type=chunk) [Outstanding Shares](index=2&type=section&id=Outstanding%20Shares) As of August 5, 2025, TG Therapeutics, Inc. had 158,665,613 shares of common stock outstanding Common Stock Outstanding | As of Date | Common Stock Outstanding | | :--------- | :----------------------- | | August 5, 2025 | 158,665,613 shares | [Table of Contents](index=3&type=section&id=TABLE%20OF%20CONTENTS) This section provides an organized listing of all chapters and sub-sections contained within the report [Special Cautionary Notice Regarding Forward-Looking Statements](index=4&type=section&id=SPECIAL%20CAUTIONARY%20NOTICE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section provides a cautionary notice regarding forward-looking statements, highlighting inherent risks and uncertainties [Forward-Looking Statements Disclosure](index=4&type=section&id=Forward-Looking%20Statements%20Disclosure) This section highlights that the Quarterly Report contains forward-looking statements, subject to safe harbor provisions, which involve risks and uncertainties that could cause actual results to differ - All statements other than historical facts may constitute forward-looking statements, subject to safe harbor provisions of the Private Securities Litigation Reform Act of 1995[9](index=9&type=chunk) - Forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from expressed or implied expectations[9](index=9&type=chunk) - Readers are cautioned not to rely unduly on any forward-looking statements, which speak only as of the report date, and the company does not undertake to update them except as required by law[10](index=10&type=chunk)[11](index=11&type=chunk) [Key Areas of Forward-Looking Statements](index=4&type=section&id=Key%20Areas%20of%20Forward-Looking%20Statements) Forward-looking statements cover critical aspects of operations, including regulatory approvals, commercialization, supply chain, clinical trials, intellectual property, financial projections, and funding - Ability to obtain and maintain regulatory approvals for product candidates (azer-cel) and BRIUMVI in various jurisdictions (U.S., EU, UK, Switzerland, Australia) - Ability to adapt and expand commercial infrastructure for BRIUMVI and other product candidates - Maintenance of a reliable supply of products to meet market demand - Timing and success of BRIUMVI commercialization, market acceptance, pricing, and reimbursement - Initiation, timing, progress, and results of preclinical studies and clinical trials - Ability to advance drug candidates into and successfully complete clinical trials - Ability to develop, formulate, manufacture, and commercialize product candidates - Ability to establish and maintain contractual relationships and partnerships for manufacturing, distribution, marketing, and supply - Implementation of business model and strategic plans - Scope of intellectual property protection for products and candidates - Estimates of expenses, future revenues, capital requirements, and need for additional financing - Ability to maintain or obtain adequate product liability and other insurance coverage - Effects of future regulatory developments or legislative actions - Prevailing economic, market, and business conditions - Ability to retain, attract, and hire key personnel - Competitive position and fluctuations in common stock trading price[12](index=12&type=chunk) [Summary Risk Factors](index=5&type=section&id=SUMMARY%20RISK%20FACTORS) This section provides a high-level overview of the principal risks associated with investing in the company [Overview of Principal Risks](index=5&type=section&id=Overview%20of%20Principal%20Risks) This section summarizes principal investment risks, categorized by commercialization, financial position, drug development, regulatory, third-party dependence, intellectual property, business organization, and common stock - The business is subject to numerous risks, and investors should carefully consider these risks before making an investment decision[13](index=13&type=chunk) - Risks Related to Commercialization - Risks Related to our Financial Position and Need for Additional Capital - Risks Related to Drug Development and Regulatory Approval - Risks Related to Governmental Regulation of the Pharmaceutical Industry and Legal Compliance Matters - Risks Related to our Dependence on Third Parties - Risks Related to Intellectual Property - Risks Related to Our Business Organization and Governance, Strategy, Employees and Growth Management - Risks Related to Our Common Stock and Being a Publicly Traded Company[14](index=14&type=chunk)[15](index=15&type=chunk)[16](index=16&type=chunk)[18](index=18&type=chunk)[19](index=19&type=chunk)[20](index=20&type=chunk)[21](index=21&type=chunk) [Specific Summary Risks](index=5&type=section&id=Specific%20Summary%20Risks) Key summary risks include limited revenues from product acceptance, undesirable side effects, intense competition, unfavorable pricing, significant operating losses, need for additional capital, regulatory challenges, third-party dependence, intellectual property, and growth management - Limited revenues if BRIUMVI or future product candidates do not achieve broad market acceptance among physicians, patients, and payors - Risk of undesirable side effects post-approval for BRIUMVI or other product candidates, leading to negative consequences - Market opportunities for BRIUMVI and azer-cel may be smaller than estimated, adversely affecting revenue and profitability - Substantial competition from other pharmaceutical companies may reduce or eliminate commercial opportunities - BRIUMVI and future products may face unfavorable pricing regulations or third-party payor coverage and reimbursement policies - Product liability lawsuits could result in substantial liabilities and limit commercialization - Significant operating losses incurred since inception, with potential for future losses - Potential need for additional capital, which if not raised, could delay or eliminate drug development and commercialization efforts - Inability to maintain or obtain regulatory approval for products and candidates, or significant delays, would materially harm the business - Preclinical and early clinical trial results are not necessarily predictive of future success, and later trials may not yield favorable results - Product candidates may cause undesirable side effects, delaying or preventing regulatory approval or impacting commercial potential - Extensive, costly, and time-consuming regulation of products and candidates, potentially causing delays or preventing approvals - New legislation, regulatory proposals, and third-party payor initiatives may increase compliance costs and adversely affect marketability - Inadequate funding or disruptions at government agencies (FDA, SEC) could hinder timely development and commercialization - Failure to comply with local laws in international markets could lead to losses - Approved products, including BRIUMVI, could face market restrictions or withdrawal, and non-compliance could result in penalties - Reliance on third parties for clinical, preclinical data, and clinical trial conduct; non-performance could delay or prevent regulatory approval and commercialization - Reliance on third parties for manufacturing and testing of BRIUMVI and clinical supply; risks of insufficient quantities, unacceptable cost, or quality - Sole source suppliers for starting materials, API/drug substance, and other materials; loss or disruption could significantly harm the business - In-licensed products (BRIUMVI, azer-cel) mean disputes or non-performance by licensors could adversely affect development and commercialization - Dependence on collaboration and commercialization partners (e.g., Neuraxpharm); unsuccessful relationships or terminations could negatively impact business and revenue - Inability to attract and retain key management, commercial, and clinical development personnel could hinder successful development or commercialization - Difficulties in managing business development and expansion could disrupt operations - Certain executive officers, directors, and principal stockholders can exercise significant influence over the company - Internal IT systems or those of third parties may fail or suffer security breaches, disrupting drug development and commercialization - Unfavorable global economic conditions could adversely affect business, financial condition, or results of operations - Stock price volatility could limit investors' ability to sell at a profit - Significant increased costs and management time devoted to public company compliance initiatives[17](index=17&type=chunk)[22](index=22&type=chunk) [PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I) This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis [ITEM 1. FINANCIAL STATEMENTS](index=7&type=section&id=Item%201%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements, including Balance Sheets, Statements of Operations, Stockholders' Equity, and Cash Flows, with detailed notes [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased from **$577.7 million** to **$702.6 million**, driven by accounts receivable and inventories, with corresponding increases in liabilities and equity Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 (Unaudited) | December 31, 2024 (Note 1) | | :-------------------------------- | :-------------------------- | :------------------------- | | **Assets** | | | | Cash and cash equivalents | $129,126 | $179,894 | | Short-term investment securities | $122,744 | $131,106 | | Accounts receivable, net | $231,516 | $129,185 | | Inventories | $155,202 | $110,458 | | Total current assets | $663,962 | $566,359 | | Total assets | $702,613 | $577,690 | | **Liabilities and Stockholders' Equity** | | | | Accounts payable and accrued expenses | $134,021 | $58,296 | | Deferred revenue - current portion | $23,911 | $11,414 | | Total current liabilities | $171,889 | $90,679 | | Loan payable – non-current | $245,037 | $244,429 | | Total liabilities | $426,181 | $355,326 | | Total stockholders' equity | $276,432 | $222,364 | | Total liabilities and stockholders' equity | $702,613 | $577,690 | - Total assets increased by **$124.9 million (21.6%)** from December 31, 2024, to June 30, 2025[25](index=25&type=chunk) - Accounts receivable, net, increased significantly by **$102.3 million (79.2%)** from December 31, 2024, to June 30, 2025[25](index=25&type=chunk) [Condensed Consolidated Statements of Operations (unaudited)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20(unaudited)) Net income substantially increased for both three and six months ended June 30, 2025, driven by more than doubled product revenue, shifting from a net loss in the prior year Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Product revenue, net | $138,843 | $72,596 | $258,498 | $123,084 | | Total revenue | $141,148 | $73,466 | $262,004 | $136,939 | | Total costs and expenses | $106,305 | $64,650 | $218,539 | $137,393 | | Operating income (loss) | $34,843 | $8,816 | $43,465 | $(454) | | Net income (loss) | $28,187 | $6,879 | $33,247 | $(3,828) | | Net income (loss) per common share: Basic | $0.19 | $0.05 | $0.23 | $(0.03) | | Net income (loss) per common share: Diluted | $0.17 | $0.04 | $0.20 | $(0.03) | - Product revenue, net, increased by **91.2%** for the three months ended June 30, 2025, compared to the same period in 2024[28](index=28&type=chunk) - Total revenue increased by **92.1%** for the three months ended June 30, 2025, compared to the same period in 2024[28](index=28&type=chunk) - Net income for the three months ended June 30, 2025, was **$28.2 million**, a significant increase from **$6.9 million** in the prior year[28](index=28&type=chunk) - For the six months ended June 30, 2025, the company reported a net income of **$33.2 million**, a substantial improvement from a net loss of **$3.8 million** in the same period of 2024[28](index=28&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity (unaudited)](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity%20(unaudited)) Total stockholders' equity increased to **$276.4 million** for the six months ended June 30, 2025, driven by net income and restricted stock compensation, partially offset by treasury stock purchases Condensed Consolidated Statements of Changes in Stockholders' Equity (in thousands) | Metric | Balance at January 1, 2025 | Balance at June 30, 2025 | | :----------------------------------- | :------------------------- | :----------------------- | | Common Stock (Shares) | 156,204,159 | 158,786,335 | | Common Stock (Amount) | $156 | $159 | | Additional paid-in capital | $1,760,396 | $1,794,212 | | Treasury Stock (Shares) | 367,903 | 761,098 | | Treasury Stock (Amount) | $(8,994) | $(21,992) | | Accumulated Deficit | $(1,529,194) | $(1,495,947) | | Total Stockholders' Equity | $222,364 | $276,432 | - Total stockholders' equity increased by **$54.1 million** from January 1, 2025, to June 30, 2025[30](index=30&type=chunk) - Net income contributed **$33.2 million** to equity during the six months ended June 30, 2025[30](index=30&type=chunk) - Purchases of treasury stock amounted to **$12.9 million** during the six months ended June 30, 2025[30](index=30&type=chunk) [Condensed Consolidated Statements of Cash Flows (unaudited)](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(unaudited)) Net cash, cash equivalents, and restricted cash decreased by **$50.8 million** for the six months ended June 30, 2025, primarily due to cash used in operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(21,279) | $(2,671) | | Net cash used in investing activities | $(16,926) | $(7,490) | | Net cash (used in) provided by financing activities | $(12,545) | $145 | | NET DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | $(50,750) | $(10,016) | | CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD | $130,442 | $84,202 | - Net cash used in operating activities increased to **$21.3 million** for the six months ended June 30, 2025, from **$2.7 million** in the prior year, mainly due to increases in accounts receivable and inventory purchases[32](index=32&type=chunk)[173](index=173&type=chunk)[174](index=174&type=chunk)[175](index=175&type=chunk) - Net cash used in investing activities increased to **$16.9 million** from **$7.5 million**, primarily due to lower maturities of short-term securities[32](index=32&type=chunk) - Net cash used in financing activities was **$12.5 million**, a shift from **$0.1 million** provided in the prior year, largely due to share repurchases[32](index=32&type=chunk) [Notes to Condensed Consolidated Financial Statements (unaudited)](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) These notes provide detailed explanations of the condensed consolidated financial statements, covering business, accounting policies, revenue, investments, inventory, fair value, equity, loans, leases, licenses, related parties, and income taxes [NOTE 1 - Organization and Summary of Significant Accounting Policies](index=11&type=section&id=NOTE%201%20-%20ORGANIZATION%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines TG Therapeutics' business as a commercial-stage biopharmaceutical company focused on B-cell diseases, with FDA and international approvals for BRIUMVI, detailing accounting policies and liquidity - TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases[35](index=35&type=chunk) - BRIUMVI (ublituximab-xiiy) has received FDA approval for relapsing forms of multiple sclerosis (RMS) and international approvals from EC, MHRA, Swissmedic, and TGA[35](index=35&type=chunk) - Accumulated deficit as of June 30, 2025: Approximately **$1.5 billion**[37](index=37&type=chunk) - Cash, cash equivalents, and investment securities as of June 30, 2025: **$278.9 million**[38](index=38&type=chunk) - Anticipated liquidity: Sufficient for more than a twelve-month period from the filing date[37](index=37&type=chunk)[38](index=38&type=chunk) [NOTE 2 - Revenue](index=16&type=section&id=NOTE%202%20-%20REVENUE) This note details disaggregated revenue, showing a significant increase in net product revenue from U.S. BRIUMVI sales, with contributions from license, milestone, royalty, and other revenue Disaggregated Revenue (in thousands) | Revenue Type | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total product revenue, net | $138,843 | $72,596 | $258,498 | $123,084 | | License, milestone, royalty and other revenue | $2,305 | $870 | $3,506 | $13,855 | | Total Revenue | $141,148 | $73,466 | $262,004 | $136,939 | - Product revenue, net, for the three months ended June 30, 2025, increased by **91.2%** year-over-year, driven by U.S. sales of BRIUMVI[70](index=70&type=chunk) - For the six months ended June 30, 2025, product revenue, net, increased by **110.0%** year-over-year[70](index=70&type=chunk)[71](index=71&type=chunk) - License, milestone, royalty and other revenue for the six months ended June 30, 2024, included a **$12.5 million** milestone payment from Neuraxpharm for the first EU commercial launch of BRIUMVI[73](index=73&type=chunk) [NOTE 3 - Investment Securities](index=17&type=section&id=NOTE%203%20-%20INVESTMENT%20SECURITIES) This note details investment securities, primarily held-to-maturity obligations of domestic governmental agencies, totaling **$149.7 million** at amortized cost as of June 30, 2025 Investment Securities (in thousands) | Metric | June 30, 2025 (Amortized Cost) | December 31, 2024 (Amortized Cost) | | :----------------------------------- | :------------------------------- | :------------------------------- | | Short-term obligations of domestic governmental agencies | $122,744 | $131,106 | | Long-term obligations of domestic governmental agencies | $26,990 | $0 | | Total short-term and long-term investment securities | $149,734 | $131,106 | | Estimated fair value (June 30, 2025) | $149,766 | $131,170 | - All investment securities are classified as held-to-maturity and recorded at amortized cost[74](index=74&type=chunk) - Equity securities from the Precision License Agreement are included in long-term investments[75](index=75&type=chunk) [NOTE 4 - Inventory](index=17&type=section&id=NOTE%204%20-%20INVENTORY) Inventory increased to **$155.2 million** at June 30, 2025, primarily due to a rise in work-in-process for BRIUMVI, with no reserves for excess or obsolescence required Inventory (in thousands) | Inventory Type | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | Raw Materials | $4,119 | $28,151 | | Work in Process | $129,239 | $68,369 | | Finished Goods | $21,844 | $13,938 | | Total Inventory | $155,202 | $110,458 | - Total inventory increased by **$44.7 million (40.5%)** from December 31, 2024, to June 30, 2025[76](index=76&type=chunk) - Work in Process inventory more than doubled, reflecting efforts to build inventory for BRIUMVI[76](index=76&type=chunk) - Inventory is solely related to BRIUMVI, with costs capitalized after FDA approval in December 2022[77](index=77&type=chunk)[78](index=78&type=chunk) - No reserve for excess quantities or obsolescence was required for BRIUMVI inventory as of June 30, 2025[79](index=79&type=chunk) [NOTE 5 - Fair Value Measurements](index=18&type=section&id=NOTE%205%20-%20FAIR%20VALUE%20MEASUREMENTS) This note details fair value measurements of financial assets and liabilities, categorized into Level 1, 2, and 3, including equity investments, forward contract liabilities, and 5% Notes Fair Value Measurements (in thousands) | Category | Level 1 | Level 2 | Level 3 | Total | | :----------------------- | :------ | :------ | :------ | :---- | | **Assets (June 30, 2025)** | | | | | | Equity Investments | $1,336 | $— | $— | $1,336 | | Total Assets | $1,336 | $— | $— | $1,336 | | **Liabilities (June 30, 2025)** | | | | | | Forward Contract Liabilities | $— | $1,404 | $— | $1,404 | | 5% Notes | $— | $— | $810 | $810 | | Total Liabilities | $— | $1,404 | $810 | $2,214 | - Equity investments primarily consist of common stock of Precision BioSciences, Inc., acquired through the Precision License Agreement for azer-cel[81](index=81&type=chunk) - Forward contract liabilities are valued using Precision's stock price and the probability of achieving Milestone Event 1[86](index=86&type=chunk) - The 5% Notes are classified as Level 3 liabilities, representing their fair value and related accrued interest[89](index=89&type=chunk) [NOTE 6 - Stockholders' Equity](index=20&type=section&id=NOTE%206%20-%20STOCKHOLDERS%27%20EQUITY) This note details stockholders' equity components, including common stock and equity incentive plans, highlighting **$12.9 million** in share repurchases and **$31.3 million** in stock-based compensation for the six months ended June 30, 2025 - Authorized common stock: **190,000,000 shares ($0.001 par value)**[96](index=96&type=chunk) - Share repurchase program: Up to **$100 million** authorized in August 2024; **$6.9 million** spent on repurchasing **193,500 shares** during the three months ended June 30, 2025[99](index=99&type=chunk) - Treasury stock held as of June 30, 2025: **761,098 shares** at a cost of **$22.0 million**[102](index=102&type=chunk) - Total stock-based compensation expense for six months ended June 30, 2025: **$31.3 million** (vs. **$18.8 million** in 2024)[103](index=103&type=chunk) - Unrecognized compensation expense for unvested time-based restricted stock: **$68.3 million** (weighted-average period of **3.0 years**)[103](index=103&type=chunk) - Unrecognized compensation expense for unvested milestone-based restricted stock: **$20.4 million**[103](index=103&type=chunk) - Unrecognized compensation expense for restricted stock with market conditions: **$46.1 million** (weighted-average period of **2.3 years**)[103](index=103&type=chunk) [NOTE 7 - Loan Payable](index=22&type=section&id=NOTE%207%20-%20LOAN%20PAYABLE) This note details the company's **$250 million** Initial Term Loan facility with Blue Owl Capital Corporation, maturing in August 2029, accruing SOFR-based interest, and secured by substantially all company assets - The company entered into a **$250 million** Initial Term Loan facility in August 2024 with Blue Owl Capital Corporation[107](index=107&type=chunk) - Loan Maturity Date: August 2, 2029[108](index=108&type=chunk) - Interest Rate: Applicable margin plus Term SOFR (no less than **1.00%**) or a base rate[109](index=109&type=chunk) - Security: Secured by a lien on substantially all assets of the company and certain subsidiaries[110](index=110&type=chunk) - Scheduled quarterly amortization payments: **$12.5 million**, commencing June 30, 2028 (may be deferred based on Total Net Leverage Ratio)[108](index=108&type=chunk) - Total financing and upfront costs: **$6.0 million**, amortized over the loan term[108](index=108&type=chunk) - Amortization of debt issuance and discount costs for six months ended June 30, 2025: **$0.6 million**[108](index=108&type=chunk) Loan Payable Balance (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :----------------------------------- | :------------ | :---------------- | | Loan payable | $250,000 | $250,000 | | Less: unamortized debt issuance and debt discount costs | $(4,963) | $(5,571) | | Total loan payable | $245,037 | $244,429 | | Loan payable non-current | $245,037 | $244,429 | [NOTE 8 - Leases](index=23&type=section&id=NOTE%208%20-%20LEASES) This note details the company's lease obligations for office spaces, with a total lease liability of **$8.7 million** and a corresponding Right-of-Use (ROU) asset of **$6.7 million** as of June 30, 2025 - Office Agreement with Fortress Biotech, Inc. (FBIO) for New York City office space, with an average annual rental obligation of **$1.8 million**[112](index=112&type=chunk) - NC Lease for North Carolina office space, with an average annual rental obligation of **$0.2 million**[113](index=113&type=chunk) - Weighted-average remaining operating lease term: **5.2 years** as of June 30, 2025[114](index=114&type=chunk) - Weighted-average discount rate for operating leases: **10.07%** as of June 30, 2025[114](index=114&type=chunk) Lease Liabilities (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :----------------------- | :------------ | :---------------- | | Lease liability current portion | $1,091 | $1,157 | | Lease liability non-current | $7,588 | $8,133 | | Total lease liability | $8,679 | $9,290 | Lease Expense (in thousands) | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :----------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Operating lease cost | $474 | $551 | $978 | $1,151 | [NOTE 9 - License Agreements](index=24&type=section&id=NOTE%209%20-%20LICENSE%20AGREEMENTS) This note details key license agreements for BRIUMVI and azer-cel, involving upfront payments, milestone payments, and tiered royalties, contributing to the company's revenue and R&D pipeline - LFB License Agreement for ublituximab (BRIUMVI): Exclusive worldwide rights (excluding France/Belgium). Royalties escalate from mid-single digits to high-single digits on net sales. **$14.2 million** and **$26.2 million** recorded in cost of revenue for three and six months ended June 30, 2025, respectively[116](index=116&type=chunk)[117](index=117&type=chunk) - Ildong Pharmaceutical Co. Ltd. Sublicense: Exclusive rights for ublituximab in South Korea and Southeast Asia. Upfront payment of **$2.0 million** (received Dec 2012) recognized as license revenue over agreement life. Potential for up to **$5.0 million** in additional milestone payments and royalties on net sales[118](index=118&type=chunk)[119](index=119&type=chunk) - Neuraxpharm Commercialization Agreement: Exclusive right to commercialize BRIUMVI ex-U.S. (excluding Canada, Mexico, and certain Asian countries). Received **$140.0 million** upfront and **$12.5 million** milestone payment upon first EU launch (Feb 2024). Eligible for up to **$492.5 million** in additional milestones and tiered double-digit royalties up to **30%**. Royalty revenue of **$1.1 million** and **$1.7 million** recognized for three and six months ended June 30, 2025, respectively[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk)[125](index=125&type=chunk) - Precision License Agreement for azer-cel: Exclusive/non-exclusive license rights for azer-cel (allogeneic CAR T therapy) for autoimmune/non-oncology diseases. Upfront payment of **$7.5 million** (**$5.25 million** cash, **$2.25 million** equity). Deferred payment of **$2.5 million** (equity) made in Jan 2025. Eligible for up to **$288 million** in additional clinical, regulatory, and commercial milestones, plus high-single-digit to low-double-digit royalties on net sales[127](index=127&type=chunk)[128](index=128&type=chunk) - MaxCyte Strategic Platform License Agreement: Non-exclusive license for MaxCyte's cell loading technology for autoimmune/non-oncology diseases, including azer-cel. Eligible for **$1.0 million** payment upon first pivotal trial dosing and up to **$13 million** in additional regulatory marketing approval milestones. Low-single-digit royalties on net sales of approved products developed with licensed technology. Annual licensing fee of approximately **$0.2 million**[127](index=127&type=chunk)[128](index=128&type=chunk) [NOTE 10 - Related Party Transactions](index=26&type=section&id=NOTE%2010%20-%20RELATED%20PARTY%20TRANSACTIONS) This note discloses related party transactions, primarily the Shared Services Agreement with Fortress Biotech, Inc. (FBIO), with expenses of approximately **$0.8 million** for the six months ended June 30, 2025 - The company has a Shared Services Agreement with Fortress Biotech, Inc. (FBIO) to share costs for facilities, personnel, and administrative services[130](index=130&type=chunk) Related Party Expenses (in thousands) | Metric | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :----------------------- | :----------------------------- | :----------------------------- | | Shared Services Agreement Expenses | $800 | $900 | - Mr. Weiss, the company's Chairman and CEO, also serves as a director and Executive Vice Chairman, Strategic Development of FBIO[130](index=130&type=chunk) [NOTE 11 - Income Taxes](index=26&type=section&id=NOTE%2011%20-%20INCOME%20TAXES) This note details the company's income tax expense of **$3.1 million** and an effective tax rate of **8.6%** for the six months ended June 30, 2025, influenced by state taxes, R&D credits, and valuation allowance changes Income Tax Information (in thousands) | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :----------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net income (loss) before taxes | $30,920 | $6,551 | $36,388 | $(4,127) | | Income tax benefit (expense) | $(2,733) | $328 | $(3,141) | $299 | | Effective tax rate | 8.8% | (5.0)% | 8.6% | 7.2% | - The effective tax rate for the six months ended June 30, 2025, was **8.6%**, differing from the federal statutory rate due to state income taxes, R&D tax credit, and change in valuation allowance[132](index=132&type=chunk) - The One Big Beautiful Bill Act (OBBBA), enacted July 4, 2025, includes significant changes to federal tax law, which the company is evaluating for future impact[134](index=134&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=26&type=section&id=Item%202%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on financial performance, highlighting increased product revenue, pipeline progress, operating expenses, liquidity, capital resources, and critical accounting policies [Overview](index=27&type=section&id=OVERVIEW) TG Therapeutics is a commercial-stage biopharmaceutical company focused on B-cell diseases, with FDA and international approvals for BRIUMVI, actively pursuing portfolio expansion opportunities - TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases[137](index=137&type=chunk) - BRIUMVI (ublituximab-xiiy) is approved by the FDA, EC, MHRA, Swissmedic, and TGA for relapsing forms of multiple sclerosis (RMS)[137](index=137&type=chunk) [Our Products and Pipeline](index=27&type=section&id=OUR%20PRODUCTS) The company's portfolio includes approved intravenous BRIUMVI for RMS, with ongoing development for a subcutaneous formulation, and azer-cel in Phase 1 clinical trials for progressive MS Clinical Drug Candidate Status (as of July 2025) | Clinical Drug Candidate | Initial Target Disease | Stage/Status of Development | | :---------------------- | :--------------------- | :-------------------------- | | Ublituximab IV (anti-CD20 mAb) | RMS | APPROVED | | Ublituximab Subcutaneous (anti-CD20 mAb) | RMS | Phase 3 pending initiation of patient enrollment | | Azer-cel | Progressive Forms of Multiple Sclerosis | Phase 1 | - BRIUMVI (ublituximab-xiiy) is an anti-CD20 monoclonal antibody for RMS, administered as a one-hour infusion every **24 weeks** after starting doses[140](index=140&type=chunk) - Positive topline results from ULTIMATE I & II Phase 3 trials showed significant reduction in ARR (p<**0.005**) with BRIUMVI[142](index=142&type=chunk) - Three additional patents for BRIUMVI were issued by USPTO in February 2024, extending protection through **2042**[143](index=143&type=chunk) - U.S. commercial launch of BRIUMVI occurred on January 26, 2023, following FDA approval in December 2022[144](index=144&type=chunk) - Ex-U.S. commercialization of BRIUMVI began in February 2024 in the EU (Germany) through Neuraxpharm, following EC approval in June 2023[145](index=145&type=chunk) - A Phase 1 clinical trial for subcutaneous BRIUMVI in RMS patients was initiated in August 2024, with a Phase 3 pivotal program evaluating every other month and quarterly dosing schedules[146](index=146&type=chunk)[147](index=147&type=chunk) - Azer-cel, an allogeneic CD19-directed CAR T cell therapy, received FDA clearance for an IND for progressive forms of MS in August 2024, and the first patient was dosed in a Phase 1 trial in August 2025[148](index=148&type=chunk) [Results of Operations](index=30&type=section&id=RESULTS%20OF%20OPERATIONS) The company experienced significant revenue growth and a shift to net income for the three and six months ended June 30, 2025, driven by increased BRIUMVI sales, alongside rising operating expenses for R&D and commercialization Summary of Results of Operations (in thousands) | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Product revenue, net | $138,843 | $72,596 | $258,498 | $123,084 | | License, milestone, royalty and other revenue | $2,305 | $870 | $3,506 | $13,855 | | Total Revenue | $141,148 | $73,466 | $262,004 | $136,939 | | Cost of revenue | $18,938 | $8,304 | $34,479 | $13,745 | | Total research and development | $31,782 | $17,556 | $78,144 | $50,278 | | Total selling, general and administrative | $55,585 | $38,790 | $105,916 | $73,370 | | Total costs and expenses | $106,305 | $64,650 | $218,539 | $137,393 | | Operating income (loss) | $34,843 | $8,816 | $43,465 | $(454) | | Net income (loss) | $28,187 | $6,879 | $33,247 | $(3,828) | - Product revenue, net, increased by **91.2%** (QoQ) and **110.0%** (YoY) due to greater market penetration of BRIUMVI in the U.S[150](index=150&type=chunk)[151](index=151&type=chunk) - License, milestone, royalty and other revenue for the six months ended June 30, 2024, included a **$12.5 million** milestone from Neuraxpharm, leading to a YoY decrease in this category for 2025[153](index=153&type=chunk)[154](index=154&type=chunk) - Cost of revenue increased due to higher royalties and manufacturing costs as previously expensed inventory was depleted[155](index=155&type=chunk)[156](index=156&type=chunk) - Total R&D expenses increased by **81.0%** (QoQ) and **55.4%** (YoY), driven by ublituximab subcutaneous development, increased clinical trial expenses, and personnel costs[157](index=157&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk) - Total selling, general and administrative expenses increased by **43.3%** (QoQ) and **44.3%** (YoY), primarily due to commercialization efforts for BRIUMVI[161](index=161&type=chunk)[162](index=162&type=chunk) - Interest expense increased due to the Initial Term Loan with Blue Owl[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk)[168](index=168&type=chunk) - Other income increased due to higher interest income from investments[169](index=169&type=chunk)[170](index=170&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) Despite recently generating net income, the company has an accumulated deficit of approximately **$1.5 billion** and holds **$278.9 million** in cash and investments, projected to provide sufficient liquidity for over twelve months, though future operations may require additional financing - The company has incurred significant operating losses since inception, with an accumulated deficit of approximately **$1.5 billion** as of June 30, 2025[171](index=171&type=chunk) - Cash, cash equivalents, and investment securities as of June 30, 2025: **$278.9 million**[172](index=172&type=chunk) - Projected liquidity: Sufficient for more than a twelve-month period from the filing date[172](index=172&type=chunk) - Future financing: May be dependent on significant future financing to execute ongoing and future operations[172](index=172&type=chunk) Summary of Cash Flows (in thousands) | Cash Flow Activity | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :----------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(21,279) | $(2,671) | | Net cash used in investing activities | $(16,926) | $(7,490) | | Net cash (used in) provided by financing activities | $(12,545) | $145 | [Off-Balance Sheet Arrangements](index=34&type=section&id=OFF-BALANCE%20SHEET%20ARRANGEMENTS) The company has not entered into any off-balance sheet arrangements involving financial guarantees, subordinated interests, derivative instruments, or other contingent arrangements exposing it to material risks - The company has not entered into any off-balance sheet arrangements that expose it to material continuing risks, contingent liabilities, or other obligations under a variable interest in an unconsolidated entity[176](index=176&type=chunk) [Critical Accounting Policies and Accounting Estimates](index=34&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES%20AND%20ACCOUNTING%20ESTIMATES) This section identifies revenue recognition and stock-based compensation expenses as critical accounting policies due to significant judgment, subjectivity, and complexity in making estimates about uncertain matters - Critical accounting policies include revenue recognition and stock-based compensation expenses[177](index=177&type=chunk) - These policies require management's most difficult, subjective, or complex judgments due to inherent uncertainties[177](index=177&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=34&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that its exposure to market risk has not materially changed since the disclosure in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024 - Market risk exposure has not materially changed since the disclosure in the Annual Report on Form 10-K for the fiscal year ended December 31, 2024[178](index=178&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=35&type=section&id=Item%204%20Controls%20and%20Procedures) This section confirms the effectiveness of the company's disclosure controls and procedures as of June 30, 2025, and reports no material changes in internal control over financial reporting during the quarter - As of June 30, 2025, the company's disclosure controls and procedures were effective[179](index=179&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[180](index=180&type=chunk) [PART II. OTHER INFORMATION](index=35&type=section&id=PART%20II) This section provides additional information beyond financial statements, covering legal proceedings, risk factors, equity sales, defaults, and exhibits [ITEM 1. LEGAL PROCEEDINGS](index=35&type=section&id=Item%201%20Legal%20Proceedings) The company and its subsidiaries are not currently involved in any material pending legal proceedings - The company and its subsidiaries are not a party to, and their property is not the subject of, any material pending legal proceedings[181](index=181&type=chunk) [ITEM 1A. RISK FACTORS](index=35&type=section&id=Item%201A%20Risk%20Factors) This comprehensive section details various risks that could materially harm the company's business, financial condition, or operating results, spanning commercialization, financial stability, drug development, regulatory, third-party dependence, intellectual property, business organization, and common stock factors - Investors should carefully consider the detailed risk factors before making an investment decision, as an investment in the company's securities is speculative and involves a high degree of risk[182](index=182&type=chunk) [Risks Related to Commercialization](index=35&type=section&id=Risks%20Related%20to%20Commercialization) Commercialization risks include potential for limited market acceptance, undesirable side effects post-approval, intense competition, unfavorable pricing, and product liability lawsuits, all limiting revenue and profitability - If BRIUMVI or future product candidates do not achieve broad market acceptance among physicians, patients, and payors, revenues will be limited[183](index=183&type=chunk)[184](index=184&type=chunk) - Regulatory approvals may be subject to limitations or post-marketing requirements, or the company may be unable to maintain marketing approval for BRIUMVI[186](index=186&type=chunk)[187](index=187&type=chunk) - BRIUMVI or future approved products may cause undesirable side effects after commercialization, leading to significant negative consequences[189](index=189&type=chunk)[190](index=190&type=chunk)[191](index=191&type=chunk) - Market opportunities for BRIUMVI and azer-cel may be smaller than estimated, adversely affecting revenue and profitability[192](index=192&type=chunk)[194](index=194&type=chunk) - Substantial competition from other pharmaceutical companies may reduce or eliminate commercial opportunities[195](index=195&type=chunk)[196](index=196&type=chunk)[197](index=197&type=chunk) - BRIUMVI and future products may become subject to unfavorable pricing regulations or third-party payor coverage and reimbursement policies[200](index=200&type=chunk)[201](index=201&type=chunk)[202](index=202&type=chunk) - Product liability lawsuits could result in substantial liabilities and limit commercialization[203](index=203&type=chunk)[204](index=204&type=chunk) - Inability to expand commercialization operations may hinder successful commercialization of BRIUMVI or other approved product candidates[207](index=207&type=chunk)[209](index=209&type=chunk) [Risks Related to Our Financial Position and Need for Additional Capital](index=41&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) The company faces risks from significant operating losses, potential need for additional capital that could dilute stockholders or impose restrictions, and the indebtedness from its **$250 million** term loan facility, which creates debt service obligations and operating restrictions - The company has incurred significant operating losses since inception and may incur future losses, requiring substantial revenue generation to maintain profitability[212](index=212&type=chunk)[213](index=213&type=chunk) - Development of pharmaceuticals is capital-intensive; significant additional funding may be required, which might not be available on favorable terms[214](index=214&type=chunk)[216](index=216&type=chunk) - Raising additional capital could dilute stockholders, restrict operations, or require relinquishing rights to technologies or drug candidates[217](index=217&type=chunk)[220](index=220&type=chunk) - Limited resources may cause the company to forego or delay pursuit of programs or product candidates with greater commercial opportunity[221](index=221&type=chunk)[222](index=222&type=chunk) - The **$250 million** Initial Term Loan facility creates indebtedness and debt service obligations that could adversely affect financial condition[223](index=223&type=chunk)[224](index=224&type=chunk) - Failure to satisfy debt obligations could result in acceleration of amounts due, potentially leading to delays or termination of development/commercialization efforts[225](index=225&type=chunk)[227](index=227&type=chunk) - The Financing Agreement imposes operating restrictions, limiting the company's ability to dispose of assets, incur additional debt, or pay dividends[228](index=228&type=chunk)[229](index=229&type=chunk) - Cash and cash equivalents could be adversely affected if financial institutions holding them fail[229](index=229&type=chunk) [Risks Related to Drug Development and Regulatory Approval](index=45&type=section&id=Risks%20Related%20to%20Drug%20Development%20and%20Regulatory%20Approval) Drug development and regulatory approval risks are substantial, including delays or failure to obtain approval, unreliability of early trial results, unexpected side effects, and the lengthy, expensive, and uncertain clinical development process, further complicated by biologics and subcutaneous formulations - Inability to maintain or obtain regulatory approval for products and candidates, or significant delays, would materially harm the business[232](index=232&type=chunk)[233](index=233&type=chunk) - Preclinical and early clinical trial results are not necessarily predictive of future results; later trials may not be favorable or receive regulatory approval[234](index=234&type=chunk)[237](index=237&type=chunk) - Interim, 'top-line,' and preliminary data from clinical trials may change upon comprehensive review, impacting the perceived product profile[238](index=238&type=chunk)[239](index=239&type=chunk) - Clinical drug development is lengthy, expensive, and uncertain; additional costs or delays may occur, or development may be unable to be completed[240](index=240&type=chunk)[241](index=241&type=chunk)[242](index=242&type=chunk) - Biologics carry unique risks and uncertainties, including limited access to biological materials and complex manufacturing regulations[243](index=243&type=chunk)[244](index=244&type=chunk)[245](index=245&type=chunk) - Product candidates may cause undesirable side effects, delaying or preventing regulatory approval or impacting commercial potential[247](index=247&type=chunk)[248](index=248&type=chunk)[249](index=249&type=chunk) - Extensive regulation of clinical development, manufacturing, and marketing can be costly, time-consuming, and cause unanticipated delays or prevent approvals[250](index=250&type=chunk)[251](index=251&type=chunk)[252](index=252&type=chunk)[253](index=253&type=chunk) - Focusing efforts on BRIUMVI and azer-cel for specific indications may lead to failure to capitalize on other potentially more profitable opportunities[255](index=255&type=chunk) - Breakthrough Therapy or Fast Track designations may not lead to faster development or approval[257](index=257&type=chunk)[258](index=258&type=chunk) - Unsuccessful in obtaining or maintaining orphan drug designation benefits, including market exclusivity[259](index=259&type=chunk)[260](index=260&type=chunk) - Clinical trials conducted outside the U.S. may be impacted by political conditions or international conflict, and data may not be accepted by regulatory authorities[261](index=261&type=chunk)[262](index=262&type=chunk)[263](index=263&type=chunk) - Approval in the U.S. does not assure approval in foreign jurisdictions[264](index=264&type=chunk)[265](index=265&type=chunk) - Clinical and commercial manufacturing site additions and process improvements may affect timely delivery or quality of products[266](index=266&type=chunk)[267](index=267&type=chunk)[268](index=268&type=chunk)[269](index=269&type=chunk][270](index=270&type=chunk)[271](index=271&type=chunk)[272](index=272&type=chunk)[273](index=273&type=chunk) - Inability to successfully develop, obtain regulatory approval for, or commercialize a subcutaneous formulation of BRIUMVI could limit market opportunity and patient reach[274](index=274&type=chunk)[276](index=276&type=chunk)[277](index=277&type=chunk)[278](index=278&type=chunk) [Risks Related to Governmental Regulation of the Pharmaceutical Industry and Legal Compliance Matters](index=55&type=section&id=Risks%20Related%20to%20Governmental%20Regulation%20of%20the%20Pharmaceutical%20Industry%20and%20Legal%20Compliance%20Matters) The heavily regulated pharmaceutical industry exposes the company to risks from new legislation, regulatory proposals, and third-party payor initiatives aimed at controlling healthcare costs and drug pricing, alongside critical compliance with fraud and abuse laws, data privacy, and evolving AI technology standards - New legislation, regulatory proposals, and third-party payor initiatives may increase compliance costs and adversely affect the ability to market products, obtain collaborators, and raise capital[279](index=279&type=chunk)[280](index=280&type=chunk) - The Affordable Care Act (ACA) and the One Big Beautiful Bill Act (OBBBA) introduce changes to healthcare coverage and tax laws that could impact the company[281](index=281&type=chunk)[282](index=282&type=chunk) - The Inflation Reduction Act (IRA) includes measures to lower prescription drug costs, such as price negotiations with Medicare and inflation-based rebates, which could reduce revenues[283](index=283&type=chunk)[285](index=285&type=chunk) - Increased competition from generic and biosimilar approvals, and state-level drug pricing controls, could exert downward pressure on product prices[286](index=286&type=chunk)[287](index=287&type=chunk) - Uncertainty regarding the impact of recent U.S. Supreme Court decisions (e.g., Loper Bright, Corner Post) and executive orders on regulatory agency authority and enforcement[288](index=288&type=chunk)[289](index=289&type=chunk) - Inadequate funding, government shutdowns, or policy changes affecting agencies like the FDA and SEC could hinder timely product development and commercialization[290](index=290&type=chunk)[291](index=291&type=chunk) - Relationships with customers and third-party payors are subject to fraud and abuse laws, false claims laws, transparency laws, and health information security laws, exposing the company to sanctions[292](index=292&type=chunk)[293](index=293&type=chunk)[294](index=294&type=chunk)[295](index=295&type=chunk][296](index=296&type=chunk)[297](index=297&type=chunk)[298](index=298&type=chunk) - Violations of data privacy and security laws (e.g., HIPAA, CCPA, GDPR) could lead to penalties, damages, fines, and operational restructuring[299](index=299&type=chunk)[300](index=300&type=chunk)[301](index=301&type=chunk)[302](index=302&type=chunk) - Adoption of AI technology may introduce risks related to defects, security breaches, data loss, and compliance with a rapidly evolving regulatory framework for AI[303](index=303&type=chunk)[304](index=304&type=chunk)[305](index=305&type=chunk) [Risks Related to Our Dependence on Third Parties](index=65&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) The company heavily relies on third parties for data generation, clinical trial conduct, and manufacturing, posing risks of delays, increased costs, or regulatory approval failures due to non-performance or non-compliance, further amplified by dependence on single-source suppliers and potential disputes with licensors or collaborators - Reliance on third parties (CROs, licensing partners) to generate clinical, preclinical, and other data for regulatory applications; non-performance could delay or prevent approval[316](index=316&type=chunk)[317](index=317&type=chunk)[318](index=318&type=chunk) - Reliance on third parties for the manufacture and testing of BRIUMVI for commercial supply and all clinical product supply; risks of insufficient quantities, unacceptable cost, or quality[319](index=319&type=chunk)[320](index=320&type=chunk)[321](index=321&type=chunk) - Sole source suppliers for starting materials, intermediates, API/drug substance, and other materials; loss or disruption could significantly harm the business[322](index=322&type=chunk)[323](index=323&type=chunk)[324](index=324&type=chunk)[325](index=325&type=chunk) - In-licensed products (BRIUMVI, azer-cel) mean disputes with or non-performance by licensors could adversely affect development and commercialization[326](index=326&type=chunk)[327](index=327&type=chunk)[328](index=328&type=chunk) - Dependence on collaboration and commercialization partners (e.g., Neuraxpharm) to develop, fund, manufacture, and commercialize drug products; unsuccessful relationships or terminations could negatively impact business and revenue[330](index=330&type=chunk)[331](index=331&type=chunk)[332](index=332&type=chunk)[333](index=333&type=chunk][334](index=334&type=chunk)[335](index=335&type=chunk)[336](index=336&type=chunk)[337](index=337&type=chunk][338](index=338&type=chunk)[339](index=339&type=chunk) - Difficulty in establishing additional collaborations on commercially reasonable terms could force alterations to development and commercialization plans[340](index=340&type=chunk)[341](index=341&type=chunk][342](index=342&type=chunk)[343](index=343&type=chunk)[344](index=344&type=chunk) [Risks Related to Our Intellectual Property](index=71&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The company's success depends on obtaining and protecting intellectual property (IP) rights, facing risks from insufficient patent breadth, validity challenges, limited lifespan, high prosecution and enforcement costs, infringement claims, need for third-party IP licenses, and potential trade secret misappropriation - Success depends on obtaining and protecting intellectual property; insufficient patent breadth could allow competitors to commercialize similar drugs[345](index=345&type=chunk)[346](index=346&type=chunk) - Patents have a limited lifespan, and the time required for drug development means patents might expire before or shortly after commercialization[347](index=347&type=chunk)[348](index=348&type=chunk) - Patent applications may not be granted, or claims may be narrowed, and the patent prosecution process is expensive and time-consuming[349](index=349&type=chunk)[350](index=350&type=chunk)[351](index=351&type=chunk) - Failure to comply with procedural requirements for obtaining and maintaining patent protection could lead to abandonment or lapse of patent rights[353](index=353&type=chunk)[354](index=354&type=chunk) - Inability to obtain patent term extensions under the Hatch-Waxman Act could shorten exclusive marketing periods[355](index=355&type=chunk)[356](index=356&type=chunk) - Enforcing intellectual property rights globally is expensive and challenging, with varying levels of protection in different countries[357](index=357&type=chunk)[358](index=358&type=chunk)[359](index=359&type=chunk) - Lawsuits to protect or enforce patents are costly, time-consuming, and may be unsuccessful, potentially leading to invalidation or narrow interpretation of patent rights[360](index=360&type=chunk)[361](index=361&type=chunk)[362](index=362&type=chunk)[363](index=363&type=chunk][364](index=364&type=chunk)[365](index=365&type=chunk)[366](index=366&type=chunk)[367](index=367&type=chunk][368](index=368&type=chunk)[369](index=369&type=chunk)[370](index=370&type=chunk)[371](index=371&type=chunk][372](index=372&type=chunk)[373](index=373&type=chunk][374](index=374&type=chunk)[375](index=375&type=chunk] - Risk of being sued for infringing third-party intellectual property rights, which could be costly, time-consuming, and result in the need for licenses or cessation of development[377](index=377&type=chunk)[378](index=378&type=chunk)[379](index=379&type=chunk)[380](index=380&type=chunk] - Inability to protect the confidentiality of trade secrets could harm business and competitive position[382](index=382&type=chunk)[383](index=383&type=chunk) - Risk of damages from claims of wrongful use or disclosure of competitors' trade secrets or breach of non-competition agreements[384](index=384&type=chunk) [Risks Related to Our Business Organization and Governance, Strategy, Employees and Growth Management](index=80&type=section&id=Risks%20Related%20to%20Our%20Business%20Organization%20and%20Governance%2C%20Strategy%2C%20Employees%20and%20Growth%20Management) The company faces risks from dependence on key personnel, challenges in managing business expansion, anti-takeover provisions, concentrated stockholder influence, limitations on net operating loss carryforwards, IT system failures, unfavorable global economic conditions, employee misconduct, and integration of future acquisitions - Failure to attract and retain key management, commercial, and clinical development personnel could hinder successful development or commercialization[386](index=386&type=chunk)[387](index=387&type=chunk) - Difficulties in managing business development and expansion, including integrating acquisitions or strategic alliances, could disrupt operations[388](index=388&type=chunk)[389](index=389&type=chunk) - Certain anti-takeover provisions in governing documents and Delaware law could make a third-party acquisition difficult, limiting stock price[390](index=390&type=chunk)[391](index=391&type=chunk) - Ability to utilize net operating loss carryforwards and other tax attributes may be limited due to ownership changes[392](index=392&type=chunk)[393](index=393&type=chunk) - Certain executive officers, directors, and principal stockholders can exercise significant influence over the company and matters submitted to stockholders for approval[394](index=394&type=chunk)[395](index=395&type=chunk) - Internal information technology systems, or those of third-party contractors, may fail or suffer security breaches, disrupting drug development and commercialization[397](index=397&type=chunk)[398](index=398&type=chunk) - Unfavorable global economic conditions, including high inflation, interest rates, and geopolitical conflicts, could adversely affect business, financial condition, or results of operations[399](index=399&type=chunk)[400](index=400&type=chunk) - Employees, principal investigators, CROs, CMOs, and consultants may engage in misconduct or improper activities, leading to criminal sanctions, civil penalties, or reputational harm[401](index=401&type=chunk) - Future acquisitions or strategic alliances may not realize expected benefits due to integration difficulties[402](index=402&type=chunk) - Adverse legislative or regulatory tax changes, such as those from the Tax Cuts and Jobs Act of 2017 and the OBBBA, could negatively impact financial condition[403](index=403&type=chunk) [Risks Related to Our Common Stock and Being a Publicly Traded Company](index=85&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock%20and%20Being%20a%20Publicly%20Traded%20Company) The company's common stock price is highly volatile, influenced by clinical results, regulatory approvals, competition, and economic conditions, with significant costs and management time devoted to public company compliance, and potential for price declines from future stock sales or an inactive trading market - Stock price is, and is expected to remain, volatile due to various factors including clinical results, regulatory approvals, competition, and economic conditions[404](index=404&type=chunk)[405](index=405&type=chunk) - The company is subject to risks related to corporate social responsibility and reputational matters, which can be influenced by ESG policies and negative publicity[407](index=407&type=chunk)[408](index=408&type=chunk) - Climate change or measures to address it may negatively affect business, supply chain, and financial condition[409](index=409&type=chunk)[410](index=410&type=chunk) - Ability to pay dividends is limited by current intentions to retain earnings and restrictions under the Financing Agreement[411](index=411&type=chunk)[412](index=412&type=chunk) - An active trading market for common stock may not be sustained, limiting investors' ability to resell shares at a profit[413](index=413&type=chunk)[414](index=414&type=chunk) - If equity research analysts publish negative evaluations or downgrade common stock, the price could decline[415](index=415&type=chunk) - Operating as a public company incurs significant increased costs and requires substantial management time for compliance initiatives, including Sarbanes-Oxley Act requirements[417](index=417&type=chunk)[418](index=418&type=chunk) - Volatility in stock price may subject the company to securities and shareholder derivative litigation, incurring substantial costs and diverting management's attention[419](index=419&type=chunk)[420](index=420&type=chunk) - Future sales of common stock, including by the company or insiders, could cause the stock price to decline[421](index=421&type=chunk) - The share repurchase program may not be fully consummated, enhance stockholder value, or could affect stock price and increase volatility, and may be suspended or terminated at any time[422](index=422&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=87&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the company's share repurchase activities, with **193,500 shares** repurchased for approximately **$6.9 million** during the three months ended June 30, 2025, under a **$100 million** authorized program with **$78.2 million** remaining Issuer Purchases of Equity Securities (April-June 2025) | Period | Total Number of Shares Purchased | Average Price Paid per Share | Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs | Maximum Number (or Approximate Dollar Value) of Shares that May Yet Be Purchased Under the Plans or Programs | | :--------------- | :------------------------------- | :--------------------------- | :----------------------------------------------------------------------------- | :---------------------------------------------------------------------------------------------------------- | | April 2025 | — | — | — | $85,117,780 | | May 2025 | 103,500 | $34.43 | 103,500 | $81,568,031 | | June 2025 | 90,000 | $37.07 | 90,000 | $78,241,866 | | Total | 193,500 | $35.75 | 193,500 | $78,241,866 | - The Board of Directors authorized a share repurchase program for up to **$100 million** of common stock in August 2024[426](ind