TG Therapeutics Inc. (NASDAQ:TGTX) Q2 2020 Earnings Conference Call August 10, 2020 8:30 AM ET Company Participants Michael Weiss - Executive Chairman, President, Chief Executive Officer Sean Power - Chief Financial Officer Jenna Bosco - Senior Vice President, Corporate Communications Conference Call Participants Josh Schimmer - Evercore ISI Ed White - HC Wainwright Matt Kaplan - Ladenburg Roger Song - Jefferies Operator Hello and welcome to the TG Therapeutics second quarter 2020 earnings conference call. ...

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, 2020 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, Inc. (NASDAQ:TGTX) Q4 2019 Results Earnings Conference Call March 3, 2020 8:00 AM ET Company Participants Jenna Bosco - VP, IR & Senior VP of Corporate Communications Sean Power - CFO, Corporate Secretary & Treasurer Michael Weiss - Executive Chairman, CEO & President Conference Call Participants Alethia Young - Cantor Fitzgerald Matt Kaplan - Ladenburg Thalmann Ed White - H.C. Wainwright & Company Chris Howerton - Jefferies Mayank Mamtani - B. Riley FBR Operator Greetings, and welcome to t ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019. 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 1-32639 TG THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 36-3898269 (Stat ...

TG THERAPEUTICS INVESTOR & ANALYST FIRESIDE CHAT EVENT TG Therapeutics ASH 2019 Investor & Analyst Event | --- | --- | --- | |-------|---------------------------------------------------|-------| | | | | | | PARTICIPANTS | | | • | Paul Barr, MD, University of Rochester | | | • | Javier Pinilla, MD, Moffitt Cancer Center | | | • | Pier Luigi Zinzani, MD, University of Bologna | | | • | Brian Koffman, MD, CLL Society | | | | | | | | Moderators | | | • | Alethia Young – Cantor Biotech Analyst | | | • | Michael ...

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 September 30, 2019 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 000-30929 ___________________________________________ TG THERAPEUTICS, INC. (Exact name of regist ...

TG Therapeutics, Inc. (NASDAQ:TGTX) Q3 2019 Earnings Conference Call November 12, 2019 8:30 AM ET Company Participants Jenna Bosco - VP, IR & SVP, Corporate Communications Sean Power - CFO, Corporate Secretary & Treasurer Michael Weiss - Executive Chairman, CEO & President Conference Call Participants Matthew Kaplan - Ladenburg Thalmann & Co. Edward White - H.C. Wainwright & Co. Christopher Howerton - Jefferies Operator Greetings. Welcome to TG Therapeutics' Third Quarter 2019 Financial Results and Business ...

Pipeline and Regulatory Strategy - TG Therapeutics is developing medicines for B-cell diseases, including Chronic Lymphocytic Leukemia (CLL), Marginal Zone Lymphoma (MZL), and Multiple Sclerosis (MS)[4,6] - The company plans to commence a rolling submission for Umbralisib in MZL around YE2019, following discussions with the FDA and a successful trial exceeding the target 40% ORR[11,22] - A regulatory submission for Umbralisib in CLL (in combination with Ublituximab) is planned for 1H2020[11] - Ublituximab's regulatory submission for CLL (in combination with umbralisib) is also planned for 1H2020, with a submission for Multiple Sclerosis expected by YE2020[11,27] Umbralisib Highlights - Umbralisib is presented as a next-generation PI3K delta inhibitor with the potential to overcome toxicities associated with first-generation PI3K-delta inhibitors, which have shown serious side effects in 16%-48% of patients[11,12] - In MZL patients, Umbralisib demonstrated an approximate 50% ORR and was deemed well-tolerated[25] - Umbralisib monotherapy showed an 85% ORR at higher doses in early clinical data for CLL[30] Ublituximab Highlights - Ublituximab is described as a next-generation anti-CD20 monoclonal antibody with enhanced potency and shorter infusion times (1-1.5 hours) compared to other anti-CD20s (3-4 hours)[28] - In a Phase 2 trial for MS, Ublituximab demonstrated a 100% reduction in T1 Gd enhancing lesions at Week 24 and Week 48 (p=0.003)[56] Market Opportunity - The global CLL market is estimated to reach over $10 billion by 2025[35] - The global MS market is estimated to be greater than $30 billion by 2025, with Ocrelizumab having over $2 billion in 2018 annual sales[61] Financial Status - As of 9/30/2019, TG Therapeutics' stock price was $5.61[68] - As of 8/2/2019, the company had approximately 94.8 million fully diluted shares[68] - As of 6/30/19, the company had approximately $97 million in cash[68]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) The company presents its unaudited condensed consolidated financial statements for the period ending June 30, 2019 [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows increased total assets driven by cash and new debt, alongside a growing accumulated deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2019 | December 31, 2018 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $57,228 | $41,958 | | Total current assets | $94,441 | $79,031 | | Total assets | $106,585 | $83,616 | | **Liabilities & Equity** | | | | Total current liabilities | $55,967 | $38,854 | | Long-term debt | $28,513 | $— | | Total liabilities | $93,380 | $59,580 | | Accumulated deficit | ($599,713) | ($528,345) | | Total stockholders' equity | $13,205 | $24,036 | - The company's total assets increased to **$106.6 million** from $83.6 million, primarily driven by an increase in cash and the addition of long-term debt, while the accumulated deficit grew to **$599.7 million**[18](index=18&type=chunk) [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statement of operations indicates a reduced net loss compared to the prior year, driven by lower operating expenses Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Q2 2019 | Q2 2018 | 6 Months 2019 | 6 Months 2018 | | :--- | :--- | :--- | :--- | :--- | | License revenue | $38 | $38 | $76 | $76 | | Total research and development | $32,866 | $38,700 | $65,251 | $73,718 | | Total general and administrative | $2,716 | $5,683 | $5,057 | $12,280 | | Operating loss | ($35,544) | ($44,345) | ($70,232) | ($85,922) | | Net loss | ($36,213) | ($44,142) | ($71,368) | ($85,671) | | Basic and diluted net loss per share | ($0.42) | ($0.59) | ($0.85) | ($1.18) | - Net loss for the second quarter of 2019 was **$36.2 million**, a decrease from $44.1 million in the same period of 2018, primarily due to lower research and development expenses and decreased noncash compensation[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow statements show significant cash used in operations, offset by cash provided by financing activities Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Activity | 2019 | 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | ($69,211) | ($62,226) | | Net cash (used in) provided by investing activities | ($678) | $7,377 | | Net cash provided by financing activities | $85,164 | $104,453 | | **Net increase in cash** | **$15,275** | **$49,604** | - For the first six months of 2019, the company used **$69.2 million** in cash for operations, while financing activities provided **$85.2 million** from stock sales and debt proceeds[27](index=27&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's focus on B-cell mediated diseases, its financial condition, and key contractual agreements - The company is a biopharmaceutical firm focused on B-cell mediated diseases, with lead candidates ublituximab and umbralisib in pivotal trials for CLL, NHL, and MS[30](index=30&type=chunk) - As of June 30, 2019, the company had an accumulated deficit of approximately **$599.7 million** and believes its cash will fund operations into the fourth quarter of 2020[34](index=34&type=chunk)[36](index=36&type=chunk) - In February 2019, the company entered into a term loan facility of up to **$60.0 million** with Hercules Capital, Inc, drawing an initial $30.0 million[98](index=98&type=chunk) - The company has an agreement with a contract manufacturer to defer payment of approximately **$20.7 million** in costs, included in current liabilities[97](index=97&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=33&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial results, clinical development progress, liquidity, and contractual obligations [Overview and Products Under Development](index=33&type=section&id=Overview%20and%20Products%20Under%20Development) The company is developing medicines for B-cell mediated diseases, with several candidates in late-stage clinical trials - TG Therapeutics is a biopharmaceutical company focused on developing medicines for B-cell mediated diseases like Chronic Lymphocytic Leukemia (CLL), non-Hodgkin Lymphoma (NHL), and Multiple Sclerosis (MS)[124](index=124&type=chunk) Advanced Drug Candidate Pipeline | Clinical Drug Candidate | Initial Target Disease | Stage of Development | | :--- | :--- | :--- | | Ublituximab (TG-1101) | Chronic Lymphocytic Leukemia | Phase 3 (UNITY-CLL) | | | Relapsing Multiple Sclerosis | Phase 3 (ULTIMATE I & II) | | Umbralisib (TGR-1202) | Chronic Lymphocytic Leukemia | Phase 3 (UNITY-CLL) | | | Marginal Zone Lymphoma | Phase 2b (UNITY-NHL) | | | Follicular Lymphoma | Phase 2b (UNITY-NHL) | | TG-1501 (anti-PDL1) | B-cell Cancers | Phase 1 | | TG-1701 (BTK inhibitor) | B-cell Cancers | Phase 1 | | TG-1801 (anti-CD47/CD19) | B-cell Cancers | Phase 1 | - The UNITY-NHL trial's Marginal Zone Lymphoma (MZL) cohort met its primary endpoint, with an anticipated **New Drug Application (NDA) submission** by year-end 2019[127](index=127&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) Operating results show a decrease in R&D expenses due to clinical program enrollment completion and an increase in interest expense from new debt Comparison of Operating Results (in millions) | Expense Category | Q2 2019 | Q2 2018 | Change | | :--- | :--- | :--- | :--- | | Other R&D Expenses | $31.4 | $34.8 | ($3.4) | | Noncash Compensation (G&A) | $0.4 | $3.4 | ($3.0) | | Interest Expense | $1.1 | $0.2 | $0.9 | - The decrease in R&D expenses for Q2 2019 was mainly due to the **completion of enrollment** in primary clinical programs during 2018[140](index=140&type=chunk) - The increase in interest expense was primarily due to the **Hercules financing agreement** executed in February 2019[143](index=143&type=chunk)[152](index=152&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is supported by cash reserves and recent financing, deemed sufficient to fund operations into late 2020 - As of June 30, 2019, the company had approximately **$85.0 million** in cash, cash equivalents, and investment securities[155](index=155&type=chunk) - Management believes that current cash, combined with capital raised in Q3 2019, is sufficient to fund planned operations into the **fourth quarter of 2020**[155](index=155&type=chunk) - Cash used in operating activities increased to **$69.2 million** for the first six months of 2019 from $62.2 million in the prior year period[156](index=156&type=chunk) - Net cash provided by financing activities in the first six months of 2019 was **$85.2 million**, from debt financing and proceeds from common stock issuance[158](index=158&type=chunk) [Contractual Obligations and Commitments](index=40&type=section&id=Contractual%20Obligations%20and%20Commitments) The company's primary contractual obligations consist of long-term debt, deferred manufacturing costs, and operating leases Contractual Obligations as of June 30, 2019 (in thousands) | Obligation | Total | Less than 1 year | 1-3 years | 3-5 years | More than 5 years | | :--- | :--- | :--- | :--- | :--- | :--- | | Long-term debt | $30,000 | $— | $30,000 | $— | $— | | Contract manufacturer | $20,738 | $20,738 | $— | $— | $— | | Operating leases | $16,410 | $1,363 | $2,707 | $2,682 | $9,658 | | **Total** | **$67,148** | **$22,101** | **$32,707** | **$2,682** | **$9,658** | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk exposure from interest rate fluctuations on its short-term investments is considered immaterial - The company's investment portfolio consists of cash equivalents and short-term government and investment-grade corporate debt[176](index=176&type=chunk) - Due to the short-term basis of its investments, the company believes there is **no material exposure** to interest rate risk or credit risk[176](index=176&type=chunk) [Item 4. Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective, with no material changes to internal controls - An evaluation of disclosure controls and procedures, supervised by the CEO and CFO, concluded that they were **effective** as of June 30, 2019[177](index=177&type=chunk)[178](index=178&type=chunk) - No changes occurred in the company's internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[179](index=179&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=44&type=section&id=Item%201.%20Legal%20Proceedings) The company and its subsidiaries are not currently party to any material pending legal proceedings - As of the filing date, the company is not a party to, and its property is not the subject of, any **material pending legal proceedings**[181](index=181&type=chunk) [Item 1A. Risk Factors](index=44&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to its financial position, debt, drug development, commercialization, and third-party dependencies [Risks Related to Our Financial Position and Need for Additional Capital](index=44&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) The company's history of significant losses and lack of revenue necessitate substantial future funding to sustain operations - The company has a limited operating history, has never generated revenue from drug sales, and has an **accumulated deficit of $599.7 million** as of June 30, 2019[183](index=183&type=chunk)[186](index=186&type=chunk) - **Substantial additional funding** will be required to continue operations, and failure to raise capital may force the company to delay or eliminate programs[190](index=190&type=chunk) [Risks Related to our Indebtedness](index=48&type=section&id=Risks%20Related%20to%20our%20Indebtedness) Debt obligations under a loan agreement are secured by company assets and carry risks of default and collateral seizure - The company has up to **$60.0 million** in debt obligations under a Loan Agreement with Hercules Capital, secured by substantially all company assets[197](index=197&type=chunk)[198](index=198&type=chunk) - Failure to satisfy debt obligations or breaching covenants could result in an **event of default**, allowing the lender to accelerate all amounts due[199](index=199&type=chunk) [Risks Related to Drug Development and Regulatory Approval](index=49&type=section&id=Risks%20Related%20to%20Drug%20Development%20and%20Regulatory%20Approval) Business success is highly dependent on completing pivotal trials and navigating the lengthy and uncertain regulatory approval process - The success of the business heavily depends on the **successful completion of pivotal trials** and obtaining regulatory approval, which is a lengthy and uncertain process[200](index=200&type=chunk)[211](index=211&type=chunk) - Early positive clinical trial results are **not predictive of future success** in larger, later-stage trials[203](index=203&type=chunk)[207](index=207&type=chunk) - A Breakthrough Therapy Designation for umbralisib in MZL **does not guarantee** a faster review or ultimate approval by the FDA[234](index=234&type=chunk) [Risks Related to Commercialization](index=60&type=section&id=Risks%20Related%20to%20Commercialization) The company faces substantial competition, market acceptance hurdles, and the need to build a commercial infrastructure - The company faces **substantial competition** from established therapies and large pharmaceutical companies with greater resources[245](index=245&type=chunk)[247](index=247&type=chunk) - Successful commercialization depends on gaining market acceptance and securing **favorable pricing and reimbursement**, which is uncertain[252](index=252&type=chunk)[258](index=258&type=chunk)[259](index=259&type=chunk) - The company currently **lacks a sales and marketing infrastructure** and must invest significantly to build a commercial organization[279](index=279&type=chunk)[280](index=280&type=chunk) [Risks Related to Our Dependence on Third Parties](index=72&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) Reliance on third-party CROs and single-source manufacturers for clinical trials and drug supply creates significant operational risks - The company relies on third-party **Contract Research Organizations (CROs)** to conduct clinical trials, and their poor performance could cause delays[294](index=294&type=chunk) - The company depends on third-party **contract manufacturers** for its drug supply, where any disruption could impair development efforts[298](index=298&type=chunk)[299](index=299&type=chunk) - Active pharmaceutical ingredients (API) and drug products are sourced from **single-source suppliers**, creating a significant risk of supply interruption[307](index=307&type=chunk)[308](index=308&type=chunk) [Risks Relating to Our Intellectual Property](index=78&type=section&id=Risks%20Relating%20to%20Our%20Intellectual%20Property) Protecting intellectual property through patents and trade secrets is critical but faces uncertainty and potential infringement claims - Commercial success depends on obtaining and maintaining **robust patent protection**, which is not guaranteed[321](index=321&type=chunk)[324](index=324&type=chunk) - The company may be sued for **infringing on the intellectual property rights** of third parties, which could be costly and halt commercialization[338](index=338&type=chunk)[341](index=341&type=chunk) - The company relies on **trade secrets and confidentiality agreements** that may be breached or provide inadequate protection[352](index=352&type=chunk) [Item 6. Exhibits](index=93&type=section&id=Item%206.%20Exhibits) This section lists key agreements and required CEO and CFO certifications filed as exhibits with the report - Key exhibits include a collaboration agreement with Checkpoint Therapeutics, Inc, and a services agreement with Samsung Biologics Co, Ltd[389](index=389&type=chunk) - Certifications from the CEO and CFO pursuant to the **Sarbanes-Oxley Act of 2002** are included as exhibits[389](index=389&type=chunk)

Financial Data and Key Metrics Changes - The net loss for Q2 2019 was approximately $36.2 million or $0.42 per share, compared to a net loss of $44.1 million or $0.59 per share in Q2 2018, indicating a reduction in net loss year-over-year [7][10] - For the six months ended June 30, 2019, the GAAP net loss was $71.4 million or $0.85 per share, down from $85.7 million or $1.18 per share in the same period of 2018 [10] - The company had cash, cash equivalents, and investment securities of $85 million as of June 30, 2019, with a pro forma cash position of approximately $97 million after raising additional proceeds [12][13] Business Line Data and Key Metrics Changes - R&D spending has decreased as registration trials in oncology and multiple sclerosis (MS) progressed, contributing to the reduced net loss compared to 2018 [8] - The company expects quarterly cash burn to average roughly $25 million for the remainder of 2019 [13] Market Data and Key Metrics Changes - The company is preparing for the NDA filing for umbralisib for accelerated approval, with a significant patient population in need of treatment for marginal zone lymphoma [27] - The market for umbralisib is estimated to have approximately 3,000 patients relapsing each year in the U.S. alone [27] Company Strategy and Development Direction - The company is focused on building its commercial team and preparing for the NDA filing around year-end, with several important milestones expected within the next 12 months [15][16] - The company aims to establish a strong presence in the marginal zone lymphoma market, viewing it as a relatively open field with significant potential [61] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming NDA submissions and the potential for successful outcomes in ongoing trials, particularly for umbralisib and the UNITY-CLL trial [28][29] - The company is confident in the tolerability and efficacy of its lead compounds, with encouraging data from clinical trials [30][31] Other Important Information - The company has received breakthrough therapy designation and orphan drug designation from the FDA for umbralisib in the treatment of marginal zone lymphoma [26] - The company is also advancing its early development pipeline with three compounds in Phase 1 and dose expansion cohorts [33] Q&A Session Summary Question: Update on timelines for follicular lymphoma - Management indicated that the expected follow-up for follicular lymphoma would likely land in late Q1 or Q2, depending on FDA expectations [38] Question: Control arms comparisons for ublituximab in CLL study - Management provided data from comparable trials, estimating a likely progression-free survival (PFS) for the control arm between 20 to 22 months [45] Question: Data expectations for venetoclax and U2 - Management anticipates around 10 patients with at least a year of follow-up, expecting a 50% complete response (CR) or minimal residual disease (MRD) negative rate [50] Question: Marginal zone lymphoma filing steps and competitive landscape - Management discussed the rate-limiting steps for the filing and noted that the market is relatively open, with umbralisib positioned as a strong treatment option [56][61] Question: Update on PDL-1 inhibitor 1501 - Management confirmed that a Phase I study is open in the U.S. for hematologic malignancies, with a combination study ongoing [83] Question: R&D spending outlook for next year - Management expects R&D spending to continue to decline as clinical trials wind down, with a modest increase in commercial activities anticipated [94]