TG Therapeutics(TGTX) - 2023 Q4 - Annual Report

Part I Business TG Therapeutics is a commercial-stage biopharmaceutical company focused on B-cell mediated diseases, with its primary product BRIUMVI approved for relapsing multiple sclerosis - The FDA approved BRIUMVI for relapsing multiple sclerosis on December 28, 2022, with its U.S. commercial launch in January 2023[26][27] - BRIUMVI also received approvals in the European Union (June 2023) and the United Kingdom (November 2023) for active RMS[28][29] - An ex-U.S. commercialization agreement for BRIUMVI with Neuraxpharm is valued at up to $645 million, including a $140 million upfront payment[50] - The company expanded its pipeline in January 2024 by licensing azer-cel, a CAR T cell therapy program for autoimmune diseases[30] Lead Drug Candidate Pipeline Status (as of February 2024) | Clinical Drug Candidate: (molecular target) | Initial Target Disease | Stage of Development (trial name) | | :--- | :--- | :--- | | Ublituximab (anti-CD20 mAb) | Relapsing Forms of Multiple Sclerosis (RMS) | APPROVED | | TG-1701 (BTK inhibitor) | B-cell disorders | Phase 1 trial | | TG-1801 (anti-CD47/CD19 bispecific mAb) | B-cell disorders | Phase 1 trial | | Azer-cel | Auto-immune disorders | Phase 1 (pending) | Risk Factors The company faces significant risks in commercializing BRIUMVI, including market acceptance, competition, financial sustainability, drug development uncertainties, and intellectual property protection - Commercial success is not guaranteed as BRIUMVI and future products may not achieve market acceptance, limiting revenue potential[146][147] - Substantial competition from larger pharmaceutical and biotech companies with greater resources poses a risk to successful drug commercialization[157] - The company has a history of significant operating losses and future profitability depends on substantial revenue from BRIUMVI and other products[173][174] - Reliance on third-party manufacturers and research organizations for supply and clinical trials increases risks of delays and quality issues[262][269] - Success depends on protecting intellectual property; insufficient patent protection could allow competitors to develop similar products, impairing commercialization[291][292] Unresolved Staff Comments The company reports no unresolved staff comments from the SEC - No unresolved staff comments are reported[359] Cybersecurity The company has implemented an information security program to mitigate cybersecurity threats, with no material impact on operations to date - Processes are implemented to mitigate risks from cybersecurity threats to critical data and IT assets[360] - The IT team leads cybersecurity efforts under management and Board oversight, with significant events reported to the CFO[363] - Cybersecurity threats have not materially affected the company to date[362] Properties The company leases all its corporate and executive office spaces across multiple locations and does not own any real property - All company facilities are leased, with no real property owned[364] Legal Proceedings The company reports that it is not a party to any material pending legal proceedings - The company and its subsidiaries are not party to any material pending legal proceedings[365] Mine Safety Disclosures This section is not applicable to the company - This item is not applicable[366] Part II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock trades on Nasdaq under 'TGTX', with no cash dividends ever paid or anticipated in the foreseeable future - The company's common stock is listed on the Nasdaq Capital Market under the symbol 'TGTX'[368] - No cash dividends have been declared or paid, nor are any anticipated in the foreseeable future[370] Removed and Reserved This item has been intentionally removed and is reserved - This item is noted as 'REMOVED AND RESERVED'[376] Management's Discussion and Analysis of Financial Condition and Results of Operations In 2023, the company achieved profitability with $12.7 million net income, driven by $233.7 million in revenue from BRIUMVI sales and a Neuraxpharm upfront payment Financial Performance Comparison (2023 vs. 2022) | (in thousands) | 2023 (in thousands) | 2022 (in thousands) | | :--- | :--- | :--- | | Total Revenue | $233,662 | $2,785 | | Product revenue, net | $92,005 | $2,633 | | License, milestone and other revenue | $141,657 | $152 | | Total costs and expenses | $213,029 | $195,624 | | Research and development | $76,192 | $125,352 | | Selling, general and administrative | $122,706 | $70,007 | | Net income (loss) | $12,672 | ($198,335) | - The significant revenue increase in 2023 was primarily due to the U.S. commercial launch of BRIUMVI and a $140.0 million upfront payment from Neuraxpharm[389][390] - Research and development expenses decreased by $48.9 million in 2023, primarily due to reduced manufacturing, lower license milestones, and clinical trial costs[393] - As of December 31, 2023, the company held $217.5 million in cash and investments, providing sufficient liquidity for over twelve months[409] Quantitative and Qualitative Disclosure About Market Risk The company's primary market risk is interest rate fluctuations on its short-term investment portfolio, which management deems not material - The company's main market risk stems from interest rate changes affecting its financial instrument portfolio[438] - Due to the short-term nature of investments, no material exposure to interest rate or credit risk is believed to exist[438] Financial Statements and Supplementary Data This item incorporates by reference the company's consolidated financial statements and related notes from Part IV of the annual report - The company's consolidated financial statements and notes are incorporated by reference[439] Changes in and Disagreements With Accountants on Accounting and Financial Disclosures This section is not applicable to the company for the reporting period - This section is not applicable[440] Controls and Procedures As of December 31, 2023, management concluded that disclosure controls and internal control over financial reporting were effective - Management concluded that disclosure controls and procedures were effective as of December 31, 2023[441] - Internal control over financial reporting was deemed effective as of December 31, 2023, audited by KPMG LLP[442][443] Other Information No directors or executive officers adopted or terminated Rule 10b5-1 trading plans during the fourth quarter of 2023 - No directors or executive officers adopted or terminated Rule 10b5-1 trading arrangements in Q4 2023[445] Part III Directors, Executive Officers and Corporate Governance Information on directors, executive officers, and corporate governance is incorporated by reference from the 2024 Proxy Statement - Information for this item is incorporated by reference from the company's 2024 Proxy Statement[446] Executive Compensation Executive compensation details are incorporated by reference from the company's 2024 Proxy Statement - Information for this item is incorporated by reference from the company's 2024 Proxy Statement[447] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Security ownership information for beneficial owners and management is incorporated by reference from the 2024 Proxy Statement - Information for this item is incorporated by reference from the company's 2024 Proxy Statement[448] Certain Relationships and Related Transactions, and Director Independence Information on certain relationships, related transactions, and director independence is incorporated by reference from the 2024 Proxy Statement - Information for this item is incorporated by reference from the company's 2024 Proxy Statement[449] Principal Accounting Fees and Services Details on principal accounting fees and services are incorporated by reference from the company's 2024 Proxy Statement - Information for this item is incorporated by reference from the company's 2024 Proxy Statement[450] Part IV Exhibits and Financial Statement Schedules This section lists the consolidated financial statements, schedules, and exhibits filed with the annual report, including auditor reports and financial statements - This item lists the consolidated financial statements of TG Therapeutics, Inc. filed as part of the report[451] - All financial statement schedules are omitted as information is either inapplicable or included in financial statements or notes[453] - A comprehensive list of exhibits filed with the report is provided, including governance documents and certifications[454]