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TG Therapeutics(TGTX) - 2024 Q1 - Quarterly Results
2024-05-01 11:05
Exhibit 99.1 TG Therapeutics Provides Business Update and Reports First Quarter 2024 Financial Results Conference call to be held today, May 1, 2024, at 8:30 AM ET First quarter 2024 BRIUMVI U.S. net revenue of $50.5 million, representing >25% quarter over quarter growth Total revenue for Q1 2024 of $63.5 million, including a $12.5 million milestone payment for BRIUMVI launch in first EU country New York, NY, (May 1, 2024) – TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) today announc ...
TG Therapeutics(TGTX) - 2023 Q4 - Annual Report
2024-02-29 22:23
Part I [Business](index=6&type=section&id=Item%201%20Business) 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](index=26&type=chunk)[27](index=27&type=chunk) - **BRIUMVI** also received approvals in the European Union (June 2023) and the United Kingdom (November 2023) for active RMS[28](index=28&type=chunk)[29](index=29&type=chunk) - An ex-U.S. commercialization agreement for **BRIUMVI** with Neuraxpharm is valued at up to **$645 million**, including a **$140 million** upfront payment[50](index=50&type=chunk) - The company expanded its pipeline in January 2024 by licensing **azer-cel**, a CAR T cell therapy program for autoimmune diseases[30](index=30&type=chunk) 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](index=24&type=section&id=Item%201A%20Risk%20Factors) 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](index=146&type=chunk)[147](index=147&type=chunk) - Substantial competition from larger pharmaceutical and biotech companies with greater resources poses a risk to successful drug commercialization[157](index=157&type=chunk) - The company has a history of significant operating losses and future profitability depends on substantial revenue from **BRIUMVI** and other products[173](index=173&type=chunk)[174](index=174&type=chunk) - Reliance on third-party manufacturers and research organizations for supply and clinical trials increases risks of delays and quality issues[262](index=262&type=chunk)[269](index=269&type=chunk) - Success depends on protecting intellectual property; insufficient patent protection could allow competitors to develop similar products, impairing commercialization[291](index=291&type=chunk)[292](index=292&type=chunk) [Unresolved Staff Comments](index=66&type=section&id=Item%201B%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - No unresolved staff comments are reported[359](index=359&type=chunk) [Cybersecurity](index=66&type=section&id=Item%201C%20Cybersecurity) 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](index=360&type=chunk) - The IT team leads cybersecurity efforts under management and Board oversight, with significant events reported to the CFO[363](index=363&type=chunk) - Cybersecurity threats have not materially affected the company to date[362](index=362&type=chunk) [Properties](index=66&type=section&id=Item%202%20Properties) 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](index=364&type=chunk) [Legal Proceedings](index=66&type=section&id=Item%203%20Legal%20Proceedings) 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](index=365&type=chunk) [Mine Safety Disclosures](index=66&type=section&id=Item%204%20Mine%20Safety%20Disclosures) This section is not applicable to the company - This item is not applicable[366](index=366&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=67&type=section&id=Item%205%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) 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](index=368&type=chunk) - No cash dividends have been declared or paid, nor are any anticipated in the foreseeable future[370](index=370&type=chunk) [Removed and Reserved](index=68&type=section&id=Item%206%20Removed%20and%20Reserved) This item has been intentionally removed and is reserved - This item is noted as 'REMOVED AND RESERVED'[376](index=376&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=69&type=section&id=Item%207%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=389&type=chunk)[390](index=390&type=chunk) - Research and development expenses decreased by **$48.9 million** in 2023, primarily due to reduced manufacturing, lower license milestones, and clinical trial costs[393](index=393&type=chunk) - As of December 31, 2023, the company held **$217.5 million** in cash and investments, providing sufficient liquidity for over twelve months[409](index=409&type=chunk) [Quantitative and Qualitative Disclosure About Market Risk](index=78&type=section&id=Item%207A%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) 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](index=438&type=chunk) - Due to the short-term nature of investments, no material exposure to interest rate or credit risk is believed to exist[438](index=438&type=chunk) [Financial Statements and Supplementary Data](index=78&type=section&id=Item%208%20Financial%20Statements%20and%20Supplementary%20Data) 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](index=439&type=chunk) [Changes in and Disagreements With Accountants on Accounting and Financial Disclosures](index=78&type=section&id=Item%209%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosures) This section is not applicable to the company for the reporting period - This section is not applicable[440](index=440&type=chunk) [Controls and Procedures](index=78&type=section&id=Item%209A%20Controls%20and%20Procedures) 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](index=441&type=chunk) - Internal control over financial reporting was deemed effective as of December 31, 2023, audited by KPMG LLP[442](index=442&type=chunk)[443](index=443&type=chunk) [Other Information](index=78&type=section&id=Item%209B%20Other%20Information) 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](index=445&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=79&type=section&id=Item%2010%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) 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](index=446&type=chunk) [Executive Compensation](index=79&type=section&id=Item%2011%20Executive%20Compensation) 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](index=447&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=79&type=section&id=Item%2012%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) 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](index=448&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=79&type=section&id=Item%2013%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) 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](index=449&type=chunk) [Principal Accounting Fees and Services](index=79&type=section&id=Item%2014%20Principal%20Accounting%20Fees%20and%20Services) 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](index=450&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=80&type=section&id=Item%2015%20Exhibits%20and%20Financial%20Statement%20Schedules) 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](index=451&type=chunk) - All financial statement schedules are omitted as information is either inapplicable or included in financial statements or notes[453](index=453&type=chunk) - A comprehensive list of exhibits filed with the report is provided, including governance documents and certifications[454](index=454&type=chunk)
TG Therapeutics(TGTX) - 2023 Q4 - Earnings Call Transcript
2024-02-28 18:14
Financial Data and Key Metrics Changes - For the fourth quarter of 2023, U.S. BRIUMVI net product revenue was $39.9 million, representing a 60% growth quarter-over-quarter, contributing to a full year revenue of approximately $234 million [41][59][62] - The company reported a net income of $12.7 million for the full year 2023, with a net loss of $14.4 million for the fourth quarter [61][62] - Operating expenses for the fourth quarter and full year were $56 million and $213 million respectively, with cash operating expenditures of approximately $47 million and $175 million [60][62] Business Line Data and Key Metrics Changes - BRIUMVI's sales momentum resulted in approximately $90 million in U.S. net revenue for its first partial year of sales [15][23] - The company reported approximately 3,200 new patient prescriptions through its hub in 2023, translating to about 3,500 total new patient scripts [43] - The fourth quarter saw a significant increase in prescriptions from major academic centers, with more scripts coming from academic centers than private practices for the first time [42] Market Data and Key Metrics Changes - The CD20 market continues to grow, capturing approximately 50% to 55% share of new patients annually, with an estimated 40,000 patients starting CD20 therapy each year [48][50] - The company estimates a 10% market share based on approximately 1,000 prescriptions received in the fourth quarter [50] Company Strategy and Development Direction - The company aims to become the number one prescribed CD20 therapy by market share, focusing on differentiating BRIUMVI through its unique attributes and patient convenience [24][25][36] - Plans include developing a subcutaneous (subcu) formulation of BRIUMVI and expanding its use beyond multiple sclerosis (MS) into other autoimmune diseases [33][34][36] - The company has recently acquired a worldwide license for an allogeneic CD19 CAR T cell therapy program, which is expected to enhance its pipeline [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong early demand for BRIUMVI, targeting $220 million to $260 million in U.S. sales revenue for 2024 [23][54] - The company is focused on lifecycle management activities for BRIUMVI and believes recent patent issuances extending protection through 2042 will provide a long runway for growth [28][116] Other Important Information - The company has received three additional patents for BRIUMVI, enhancing its competitive position and extending patent protection through 2042 [28][102] - The company ended 2023 with approximately $217.5 million in cash and equivalents, providing sufficient capital to fund operations towards cash flow positivity [62] Q&A Session Summary Question: What can we expect on growth-to-net cadence for the balance of the year? - Management indicated that while there will be variability quarter-to-quarter, they have not provided precise guidance for 2024 [71] Question: Do you have any numbers on the switches from prior therapies and how that's impacting your sales growth? - Management noted that the largest group of patients switching to BRIUMVI are those previously treated but naive to CD20 therapy, with a balanced distribution across patient types [75][76] Question: Can you give us your thoughts on the launch in Germany and in other countries? - Management highlighted the importance of launching in Germany as the largest market in Europe and mentioned that other countries will follow later this year into next year [78] Question: How should we be thinking about the growth or the ramp of SG&A expenses? - Management confirmed that most of the expansion in the sales force is already incorporated into the current operating expense estimates for 2024 [80] Question: What timeframe do you think it's possible to achieve the number one prescribed IV CD20 for BRIUMVI by dynamic share? - Management has not set a specific timeframe but is working towards this goal, indicating that 2024 may not be the year to achieve it [85] Question: How important is it to demonstrate efficacy via relapse rate compared to demonstrating comparability on bioequivalence for subcu BRIUMVI? - Management believes that a bioequivalence study will be sufficient, similar to competitors, without needing a full efficacy study [106]
TG Therapeutics(TGTX) - 2023 Q4 - Annual Results
2024-02-28 12:24
Exhibit 99.1 TG Therapeutics Provides Business Update and Reports Fourth Quarter and Year-End 2023 Financial Results Fourth quarter and full year 2023 BRIUMVI U.S. net revenue of approximately $40 million and $89 million, respectively Conference call to be held today, February 28, 2024, at 8:30 AM ET New York, NY, (February 28, 2024) – TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) today announced its financial results for the fourth quarter and year ended December 31, 2023, along wit ...
TG Therapeutics(TGTX) - 2023 Q3 - Quarterly Report
2023-11-06 22:01
[Special Cautionary Notice Regarding Forward-Looking Statements](index=4&type=section&id=SPECIAL%20CAUTIONARY%20NOTICE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section cautions that forward-looking statements involve known and unknown risks and are not guarantees of future performance - The company identifies several areas covered by forward-looking statements, including but not limited to[10](index=10&type=chunk) - Ability to obtain and maintain regulatory approvals for product candidates like TG-1701 and TG-1801, and maintain approval for BRIUMVI® - Success of the commercial launch and market acceptance of BRIUMVI® - Progress and results of pre-clinical studies and clinical trials - Estimates of expenses, future revenues, capital requirements, and financial performance - Ability to obtain sufficient capital and manage cash burn [Summary Risk Factors](index=5&type=section&id=SUMMARY%20RISK%20FACTORS) This section summarizes the principal risks impacting the company's operations, financial condition, and future prospects [Risks Related to Commercialization](index=5&type=section&id=Risks%20Related%20to%20Commercialization) This section outlines key risks associated with product commercialization, including market acceptance, intense competition, and potential for limited revenue generation - The company has limited experience as a commercial entity, which may impact the success of the BRIUMVI launch[14](index=14&type=chunk) - Market acceptance of BRIUMVI is not guaranteed and depends on factors like physician and patient adoption, pricing, and reimbursement[14](index=14&type=chunk) - Substantial competition exists from companies with greater resources, which could reduce or eliminate the commercial opportunity for the company's products[14](index=14&type=chunk) [Risks Related to Drug Development and Regulatory Approval](index=5&type=section&id=Risks%20Related%20to%20Drug%20Development%20and%20Regulatory%20Approval) This section details risks inherent in drug development and regulatory processes, including approval uncertainties, potential side effects, and the non-predictive nature of early trial results - Failure to obtain or maintain regulatory approval for products like BRIUMVI or candidates like TG-1701 and TG-1801 would materially harm the business[14](index=14&type=chunk) - Undesirable side effects could delay or prevent regulatory approval, or lead to market withdrawal if discovered post-approval[14](index=14&type=chunk) - Positive results from early-stage clinical trials do not guarantee favorable results in later, more definitive trials[14](index=14&type=chunk) [Risks Related to Dependence on Third Parties](index=6&type=section&id=Risks%20Related%20to%20our%20Dependence%20on%20Third%20Parties) This section summarizes risks from heavy reliance on third parties for manufacturing, clinical trials, and in-licensing agreements, which could disrupt operations - Reliance on third parties for manufacturing and supply of products and raw materials creates a risk of insufficient quantities or quality, which could impair commercialization[18](index=18&type=chunk) - The company depends on third parties to conduct clinical trials; poor performance by these parties could jeopardize regulatory approval[18](index=18&type=chunk) - Since products are in-licensed, any disputes or non-performance by licensors could adversely affect the ability to develop and commercialize them[18](index=18&type=chunk) [Risks Related to Intellectual Property](index=6&type=section&id=Risks%20Related%20to%20Intellectual%20Property) This section covers risks related to intellectual property, including the ability to obtain and protect patents, and potential infringement lawsuits - The company's success is dependent on its ability to obtain and protect its intellectual property. If patent protection is not sufficiently broad, competitors could develop similar products[16](index=16&type=chunk) - Lawsuits alleging infringement of third-party intellectual property rights could be costly and time-consuming, with an unfavorable outcome having a material adverse effect[16](index=16&type=chunk) [Risks Related to Financial Position and Need for Additional Capital](index=6&type=section&id=Risks%20Related%20to%20our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) This section highlights financial risks, including a history of operating losses, potential need for additional capital, and the adverse effects of indebtedness - The company has a history of significant operating losses and may incur losses in the future[17](index=17&type=chunk) - While not currently expected, the company may need to raise additional capital. An inability to do so could force a reduction in development or commercialization efforts[17](index=17&type=chunk) - The company's level of debt could adversely affect its financial condition and make it more difficult to fund operations[17](index=17&type=chunk) [PART I: FINANCIAL INFORMATION](index=7&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements](index=7&type=section&id=Item%201%20Financial%20Statements%3A) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, cash flows, and notes on key accounting policies [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a significant increase in total assets to **$331.1 million** driven by cash, receivables, and inventory, alongside an increase in total liabilities due to higher loan payable Balance Sheet Highlights (in thousands) | Metric | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $150,902 | $102,304 | | Accounts receivable, net | $39,320 | $0 | | Inventories | $33,553 | $0 | | **Total Assets** | **$331,067** | **$193,572** | | **Liabilities & Equity** | | | | Loan payable – non-current | $98,908 | $71,135 | | Total Liabilities | $166,298 | $134,985 | | Total Stockholders' Equity | $164,769 | $58,587 | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20(unaudited)) The company achieved significant profitability in Q3 2023 with **$113.9 million** net income, driven by **$140.7 million** license revenue and **$25.1 million** product sales Q3 2023 vs Q3 2022 Performance (in thousands) | Metric | Q3 2023 | Q3 2022 | | :--- | :--- | :--- | | Product revenue, net | $25,068 | $56 | | License, milestone and other revenue | $140,747 | $38 | | **Total Revenue** | **$165,815** | **$94** | | Total costs and expenses | $51,031 | $35,057 | | **Operating Income (Loss)** | **$114,784** | **($34,963)** | | **Net Income (Loss)** | **$113,930** | **($35,818)** | | Diluted EPS | $0.73 | ($0.26) | Nine Months 2023 vs 2022 Performance (in thousands) | Metric | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | | Product revenue, net | $48,868 | $2,591 | | License, milestone and other revenue | $140,823 | $114 | | **Total Revenue** | **$189,691** | **$2,705** | | Total costs and expenses | $156,573 | $143,482 | | **Operating Income (Loss)** | **$33,118** | **($140,777)** | | **Net Income (Loss)** | **$27,088** | **($145,341)** | | Diluted EPS | $0.19 | ($1.08) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(unaudited)) Net cash used in operating activities significantly decreased to **$18.2 million**, while financing activities provided **$72.7 million**, resulting in a **$48.6 million** net increase in cash for the nine months ended September 30, 2023 Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($18,203) | ($152,300) | | Net cash used in investing activities | ($5,896) | ($36,282) | | Net cash provided by (used in) financing activities | $72,706 | ($440) | | **Net Increase (Decrease) in Cash** | **$48,607** | **($189,022)** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) These notes detail the company's commercial transition, the **$140 million** Neuraxpharm agreement, liquidity, and key accounting policies for revenue, inventory, and debt - The company is now a fully-integrated, commercial-stage biopharmaceutical company following the FDA, EC, and MHRA approvals of BRIUMVI for relapsing forms of multiple sclerosis (RMS)[32](index=32&type=chunk) - The company achieved profitability in Q3 2023 due to a **$140.0 million** non-refundable upfront payment from a commercialization agreement with Neuraxpharm[35](index=35&type=chunk)[70](index=70&type=chunk) - As of September 30, 2023, the company had **$229.2 million** in cash, cash equivalents, and investment securities, which is believed to be sufficient to fund operations for at least the next twelve months[37](index=37&type=chunk)[156](index=156&type=chunk) - On March 31, 2023, the company amended its loan agreement with Hercules, drawing an additional **$25.0 million**. The total loan payable as of September 30, 2023 was **$98.9 million**[92](index=92&type=chunk)[99](index=99&type=chunk) - Costs to manufacture BRIUMVI are now capitalized as inventory following its FDA approval on December 28, 2022. Prior to this date, these costs were expensed as R&D[61](index=61&type=chunk)[76](index=76&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and results, highlighting BRIUMVI's successful launch, the Neuraxpharm agreement, and a shift to profitability [Overview and Recent Business Updates](index=29&type=section&id=Overview%20and%20Recent%20Business%20Updates) This section provides an overview of the company's transition to a commercial-stage entity, highlighting BRIUMVI's regulatory approvals and the Neuraxpharm commercialization agreement - Announced an agreement with Neuraxpharm on August 1, 2023, for the ex-U.S. commercialization of BRIUMVI[120](index=120&type=chunk)[128](index=128&type=chunk) - Received approval for BRIUMVI from the UK's MHRA on November 1, 2023, for adult patients with active RMS[120](index=120&type=chunk)[131](index=131&type=chunk) - The U.S. commercial launch of BRIUMVI began on January 26, 2023, with the first patient receiving an infusion on February 1, 2023[126](index=126&type=chunk)[129](index=129&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) Analysis of operations shows dramatic financial improvement, with total revenue surging to **$165.8 million** in Q3 2023, driven by license fees and product sales, resulting in **$113.9 million** net income Comparison of Three Months Ended September 30 (in thousands) | Item | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | **Total Revenue** | **$165,815** | **$94** | **+$165,721** | | Product revenue, net | $25,068 | $56 | +$25,012 | | License revenue | $140,747 | $38 | +$140,709 | | **Total R&D Expense** | **$14,753** | **$20,801** | **-$6,048** | | **Total SG&A Expense** | **$32,769** | **$14,254** | **+$18,515** | | **Net Income (Loss)** | **$113,930** | **($35,818)** | **+$149,748** | Comparison of Nine Months Ended September 30 (in thousands) | Item | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | **Total Revenue** | **$189,691** | **$2,705** | **+$186,986** | | Product revenue, net | $48,868 | $2,591 | +$46,277 | | License revenue | $140,823 | $114 | +$140,709 | | **Total R&D Expense** | **$58,743** | **$95,717** | **-$36,974** | | **Total SG&A Expense** | **$91,553** | **$47,503** | **+$44,050** | | **Net Income (Loss)** | **$27,088** | **($145,341)** | **+$172,429** | [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity has strengthened due to equity offerings, debt financing, and the Neuraxpharm payment, with **$229.2 million** in cash and investments deemed sufficient for the next twelve months - Major sources of cash have been equity offerings, debt financing from Hercules, and the upfront payment from the Neuraxpharm Commercialization Agreement[153](index=153&type=chunk) - As of September 30, 2023, the company had **$229.2 million** in cash, cash equivalents, and investment securities[156](index=156&type=chunk) - Management believes existing cash and projected revenues are sufficient to fund operating requirements for at least twelve months from the filing date[156](index=156&type=chunk) Cash Flow Changes (Nine Months Ended Sep 30, in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($18,203) | ($152,300) | | Net cash provided by (used in) financing activities | $72,706 | ($440) | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company reports no material changes in its market risk exposure since the Annual Report on Form 10-K for the year ended December 31, 2022 - There have been no material changes in the company's market risk exposure since the end of 2022[164](index=164&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that as of September 30, 2023, the company's disclosure controls and procedures were effective[165](index=165&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, these controls[166](index=166&type=chunk) [PART II: OTHER INFORMATION](index=38&type=section&id=PART%20II%20OTHER%20INFORMATION) This section provides additional information, including legal proceedings, detailed risk factors, and other disclosures not covered in the financial information section [Item 1. Legal Proceedings](index=38&type=section&id=Item%201%20Legal%20Proceedings) The company reports no material pending legal proceedings involving itself, its subsidiaries, or its property - The company is not currently involved in any material legal proceedings[167](index=167&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A%20Risk%20Factors) This section extensively discusses risks and uncertainties that could materially harm the company, categorized by commercialization, financial position, drug development, third-party dependence, and intellectual property [Risks Related to Commercialization](index=39&type=section&id=Risks%20Related%20to%20Commercialization) This subsection details risks associated with product commercialization, including market acceptance, intense competition, and securing adequate reimbursement - The success of BRIUMVI is uncertain and depends on market acceptance, which is influenced by efficacy, safety, pricing, reimbursement, and competition[171](index=171&type=chunk) - The company faces substantial competition from well-resourced pharmaceutical companies, which may commercialize drugs more successfully[183](index=183&type=chunk) - The ability to commercialize products depends on securing adequate coverage and reimbursement from government and private payors, who are increasingly focused on cost containment[188](index=188&type=chunk) [Risks Related to Financial Position and Need for Additional Capital](index=45&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) This part outlines financial vulnerabilities, including a history of operating losses, potential need for additional capital, and risks associated with indebtedness and restrictive covenants - The company has a history of significant operating losses and expects to continue incurring significant expenses for commercialization and R&D[198](index=198&type=chunk) - While not currently anticipated, a future need to raise capital may arise. Failure to secure funding could require delaying or reducing programs[202](index=202&type=chunk) - The company's debt obligations under its agreement with Hercules could adversely affect its financial condition and restrict operations due to covenants[211](index=211&type=chunk)[212](index=212&type=chunk) [Risks Related to Drug Development and Regulatory Approval](index=50&type=section&id=Risks%20Related%20to%20Drug%20Development%20and%20Regulatory%20Approval) This subsection covers inherent uncertainties of drug development, including high clinical trial failure rates, non-predictive early results, potential side effects, and lengthy regulatory processes - Early-stage clinical trial results are not predictive of later-stage outcomes, and product candidates face a high rate of failure[220](index=220&type=chunk) - Clinical drug development is a long, expensive, and uncertain process, with potential delays in trial completion and enrollment[227](index=227&type=chunk) - Undesirable side effects discovered during trials could delay or prevent regulatory approval, while those found after approval could impact commercial potential[237](index=237&type=chunk) [Risks Related to Dependence on Third Parties](index=66&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) This subsection details significant risks from reliance on third parties for clinical trials, manufacturing (including single sources), and in-licensing agreements - The company relies on CROs to conduct clinical trials; failure by these CROs to perform as required could delay or terminate trials[295](index=295&type=chunk) - The company depends on third-party CMOs for manufacturing, including a single source for BRIUMVI supply, which increases the risk of supply disruptions[299](index=299&type=chunk) - As products are in-licensed, any dispute with or non-performance by licensors could adversely affect the ability to commercialize the products[310](index=310&type=chunk) [Risks Relating to Intellectual Property](index=72&type=section&id=Risks%20Relating%20to%20Our%20Intellectual%20Property) This subsection discusses critical intellectual property risks, including obtaining and defending patents, potential litigation, and protecting trade secrets - Commercial success depends on obtaining and maintaining patent protection, but there is no guarantee that patent applications will issue or that issued patents will provide sufficient protection[323](index=323&type=chunk)[324](index=324&type=chunk) - The company may be involved in expensive and time-consuming lawsuits to protect its patents or defend against claims of infringing third-party patents[346](index=346&type=chunk)[353](index=353&type=chunk) - In addition to patents, the company relies on trade secrets, which are vulnerable to unauthorized disclosure or independent discovery by competitors[360](index=360&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=89&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is reported as not applicable for the period - Not applicable[397](index=397&type=chunk) [Item 5. Other Information](index=89&type=section&id=Item%205%20Other%20Information) The company reports no adoption or termination of Rule 10b5-1 trading plans by directors or executive officers during Q3 2023 - No directors or executive officers adopted or terminated a Rule 10b5-1 trading plan during the three months ended September 30, 2023[400](index=400&type=chunk) [Item 6. Exhibits](index=90&type=section&id=Item%206%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and financial statements in iXBRL format - Exhibits filed include CEO and CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[404](index=404&type=chunk) - The filing also includes financial information formatted in Inline Extensible Business Reporting Language (iXBRL)[404](index=404&type=chunk)
TG Therapeutics(TGTX) - 2023 Q3 - Earnings Call Transcript
2023-11-05 05:51
Financial Data and Key Metrics Changes - The company reported net revenue of approximately $166 million for Q3 2023, which includes $140 million from an upfront licensing fee and $25.1 million from Briumvi net sales in the U.S. [7][20] - For the nine-month year-to-date period, total net revenue reached approximately $190 million, including about $49 million in Briumvi net product sales [20]. Business Line Data and Key Metrics Changes - Briumvi's net sales for Q3 were $25.1 million, reflecting a 57% growth quarter-over-quarter, driven by new patient infusions and increased demand [16]. - The total number of new patient prescriptions for Briumvi reached approximately 2,200, capturing about 80% to 90% of the total new scripts written [16]. Market Data and Key Metrics Changes - The company estimates that around 40,000 MS patients start CD20 therapy each year in the U.S., indicating a growing market for Briumvi [16]. - The company achieved 95% coverage for commercial and Medicare lives, exceeding its corporate goal for the year [18]. Company Strategy and Development Direction - The company aims to position Briumvi as the number one prescribed anti-CD20 therapy based on dynamic market share, focusing on both IV therapy centers and potential subcutaneous formulations [8][13]. - The company is evaluating additional indications for Briumvi and exploring new product opportunities in MS and autoimmune diseases [12]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in closing out the year strong and anticipates a solid revenue target of approximately $33 million to $37 million for Q4 2023 [15]. - The company believes it has a reasonable line of sight to profitability in the near term, supported by a cash position of approximately $229 million [15][28]. Other Important Information - The company received approval for Briumvi in the United Kingdom, with expectations for a launch in early 2024 [12]. - The company plans to discontinue sharing distributor-level data with third-party companies to reduce confusion and price volatility [14]. Q&A Session Summary Question: Thoughts on anti-CD20 market penetration and infusion vs. subcutaneous injections - Management noted that while the infusion market is growing, the overall market is likely expanding faster due to subcutaneous therapies reaching new neurologists [33]. Question: Real-world number of patients switching to Briumvi - Management indicated that the number of patients switching from other CD20 therapies has been higher than expected, primarily due to the shorter infusion time and tolerability issues [35]. Question: Breakdown of patient categories using Briumvi - Management reported a balanced distribution among new patients, switches from other therapies, and returning patients, with a slight majority coming from switches from non-CD20 therapies [42]. Question: Factors affecting conversion from prescriptions to revenue - Management highlighted the time lag from hub to infusion and patient compliance as key factors influencing revenue conversion [44]. Question: Guidance for 2024 revenue - Management has not yet provided guidance for 2024 but aims to offer insights as early as possible next year [45]. Question: Impact of J-Code on growth - Management expects continued steady growth and confidence in reimbursement following the establishment of the J-Code [81]. Question: Competitiveness of BTK therapies - Management believes that BTK therapies may be viewed as oral options for relapsing MS but do not see them as direct competitors to CD20 therapies [70][77].
TG Therapeutics(TGTX) - 2023 Q2 - Quarterly Report
2023-08-04 20:30
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-32639 TG THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 36-3898269 (State or other jur ...
TG Therapeutics(TGTX) - 2023 Q2 - Earnings Call Transcript
2023-08-04 01:13
TG Therapeutics, Inc. (NASDAQ:TGTX) Q2 2023 Earnings Call Transcript August 1, 2023 8:30 AM ET Company Participants Jenna Bosco - Senior Vice President of Corporate Communications Michael Weiss - Chairman, CEO and President Adam Waldman - Chief Commercialization Officer Sean Power - CFO, Corporate Secretary and Treasurer Conference Call Participants Eric Joseph - JP Morgan Ed White - H.C. Wainwright Roger Song - Jefferies Mayank Mamtani - B. Riley Securities Michael DiFiore - Evercore Prakhar Agrawal - Cant ...
TG Therapeutics(TGTX) - 2023 Q1 - Quarterly Report
2023-05-08 11:59
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-32639 TG THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 36-3898269 (State or other ju ...
TG Therapeutics(TGTX) - 2023 Q1 - Earnings Call Transcript
2023-05-01 17:15
Financial Data and Key Metrics Changes - The company reported net product revenue of $7.8 million in the first quarter, exceeding internal expectations [31] - The net loss for Q1 2023 was approximately $32.6 million, down more than 50% from $67 million in Q1 2022, reflecting a disciplined spending approach [35] - GAAP net loss for Q1 2023 was $39.4 million or $0.28 per share, compared to a loss of $69 million or $0.51 per share in Q1 2022 [35] Business Line Data and Key Metrics Changes - BRIUMVI's launch has seen early adoption from both major academic centers and community practices, with over 165 physicians from more than 125 centers prescribing the drug [31][32] - The company has achieved coverage policies for over 50% of covered lives across the US, ahead of the mid-year goal [33] Market Data and Key Metrics Changes - The company anticipates an acceleration in prescriptions in the second half of the year as operational hurdles are addressed and the J-Code becomes effective on July 1, 2023 [33] - There is significant growth potential for the CD20 class in the EU, with positive discussions with key opinion leaders in Germany [9] Company Strategy and Development Direction - The company is evaluating its commercial pathway in Europe, considering either a solo launch or a partnership, with a decision expected in the coming months [29] - The company aims to achieve broad access to BRIUMVI with greater than 80% coverage by the end of 2023 [33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in BRIUMVI's best-in-class potential and the positive reception from healthcare providers [26][28] - The company believes that operational hurdles will continue to improve throughout the year, facilitating further growth [33] Other Important Information - The company ended the quarter with approximately $160 million in cash, which is expected to last into mid-2024 based on current revenue assumptions [30][36] - The company has capitalized $25 million in inventory on the balance sheet, which will likely be the sole campaign in 2023 [15] Q&A Session Summary Question: Can you elaborate on the mix between new to CD20 versus switches? - The company is seeing a mix of both naive and switch patients, with a broad distribution from various therapies [40][41] Question: What percentage of patients are utilizing the patient access programs? - Approximately 10% to 15% of free goods were provided, primarily through the quick-start program [49] Question: What are the expectations for R&D and SG&A expenses throughout the year? - R&D is expected to remain consistent with Q1 levels, while SG&A is also anticipated to stay stable [50][51] Question: How many patients were infused in the first quarter? - The company does not have exact numbers on infusions, as they only track prescriptions that go through the hub [55][56] Question: What was the gross to net discount for this quarter? - The gross to net discount in Q1 was 77%, with expectations for fluctuations in future quarters [60]