Table of Contents Title of Class Trading Symbol(s) Exchange Name Common Stock, par value $0.001 TGTX Nasdaq Capital Market 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, 2024 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 THE ...

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Financial Data and Key Metrics - Q3 2024 BRIUMVI US net sales were $83.3 million, reflecting a 15% quarter-over-quarter growth and over 230% growth from the same quarter last year [9][21] - Year-to-date BRIUMVI net product revenue for the first nine months of 2024 was $206.4 million [35] - GAAP net income for Q3 2024 was approximately $3.9 million or $0.02 per diluted share, while non-GAAP net income was $15.7 million [36] - Operating expenses (OpEx) for Q3 2024 were approximately $50 million, and full-year OpEx is expected to be below the guidance of $250 million [37] - The company ended Q3 2024 with approximately $341 million in cash, cash equivalents, and investment securities [38] Business Line Data and Key Metrics - BRIUMVI is the fastest-growing disease-modifying therapy (DMT) in the US MS market, with strong growth in new prescribers and treatment centers, reaching nearly 1,100 prescribers across approximately 600 centers [22] - The hospital setting is the fastest-growing segment, accounting for approximately 55% of the overall business [22] - The company is developing a subcutaneous (subcu) version of BRIUMVI, with a bioequivalent study update expected by early 2025 and a pivotal trial targeted to commence in mid-2025 [15] Market Data and Key Metrics - The anti-CD20 market in MS is expected to grow to mid-50s to 60% dynamic share, with BRIUMVI currently holding about 15% of the CD20 market [41] - The company has secured FUJIFILM Diosynth Biotechnologies as a secondary manufacturer of BRIUMVI in the US to support future growth and supply security [17] Company Strategy and Industry Competition - The company is focused on expanding BRIUMVI's market share and improving the patient experience through faster infusion times and a subcu formulation [14][15] - The company is also advancing its R&D pipeline, including a Phase 1 study for azer-cel, an off-the-shelf allogeneic CD19 CAR T-cell therapy for autoimmune diseases, targeting progressive MS [16] - The company plans to increase investments in patient awareness and marketing efforts to drive further growth in 2025 and beyond [28][32] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in BRIUMVI's long-term positioning as the preferred anti-CD20 therapy in relapsing forms of MS, supported by strong clinical data and positive feedback from healthcare providers [8][26] - The company raised its full-year guidance for BRIUMVI net US sales to $300 million to $305 million, reflecting continued strong growth [32] - Management highlighted the potential for accelerating new patient growth in 2025 as the company reaches critical mass and expands its commercial and marketing efforts [72] Other Important Information - The company commenced a share repurchase program in Q3 2024 and expects to continue it into 2025 [39] - The company is exploring opportunities to expand BRIUMVI into non-MS indications, with plans to initiate trials in 2024 and provide updates in 2025 [84][85] Q&A Session Summary Question: Market size and share expectations for anti-CD20 in MS in 2025 - The anti-CD20 market is expected to grow to mid-50s to 60% dynamic share, with BRIUMVI currently holding about 15% of the CD20 market [41] - The IV to subcu ratio is around 70% IV, with IV remaining the clear patient preference [43] Question: Impact of secondary manufacturing on gross margins - The agreement with FUJIFILM Diosynth Biotechnologies will not impact gross margins in the near term, with upfront expenditures running through R&D [42] Question: Inventory dynamics and TRx script count in Q3 - There were no changes in inventory dynamics in Q3, and the company is moving away from providing hub enrollment numbers due to fluctuating capture rates [47][48] Question: Label updates for faster infusion and skipping loading dose - Randomized trials focusing on safety and tolerability will be needed to support label updates for faster infusion and skipping the loading dose, with studies expected to start in 2025 [52] Question: Subcu BRIUMVI development and dosing interval - The company is targeting a minimum dosing interval of every other month for the subcu formulation, with bioequivalent study data expected by early 2025 [58] Question: Persistence rates compared to competitors - BRIUMVI's week 24 compliance rates are at least as good as, if not better than, published rates for other IV CD20 competitors [61] Question: Revenue split between maintenance and new patients - The revenue split is currently majority new patients, but repeat prescriptions are expected to dominate in the next several quarters [66] Question: Growth in hospital setting and new patient growth in 2025 - Approximately 60-65% of MS patients are treated in the hospital setting, which is the fastest-growing segment for BRIUMVI [74] - The company expects accelerating new patient growth in 2025 as it reaches critical mass and expands its commercial and marketing efforts [72] Question: Impact of subcu Ocrevus launch and capital allocation priorities - The company has seen no impact from the subcu Ocrevus launch and plans to continue its share buyback program while investing in BRIUMVI's growth and R&D initiatives [76][77] Question: BRIUMVI expansion to non-MS indications and azer-cel data updates - The company is working on initiating trials for non-MS indications in 2024 and expects to provide updates in 2025 [83] - The Phase 1 study for azer-cel is expected to start by the end of 2024 or early 2025, with data potentially available in the second half of 2025 [82]

TG Therapeutics (TGTX) came out with quarterly earnings of $0.02 per share, missing the Zacks Consensus Estimate of $0.04 per share. This compares to earnings of $0.73 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -50%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.04 per share when it actually produced earnings of $0.04, delivering a surprise of 200%.Over the last four quarters, ...

NEW YORK, Nov. 01, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that a conference call will be held, Monday November 4, 2024, at 8:30 AM ET to discuss results for the third quarter of 2024 and provide a business outlook for the remainder of the year. Michael S. Weiss, Chairman and Chief Executive Officer, will host the call. In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics ...

Infusion related reactions in patients receiving 30-minute BRIUMVI infusions were all mild (Grade 1) and resolved completely Data also demonstrate patients switching from prior anti-CD20 treatment can successfully eliminate initial BRIUMVI infusion NEW YORK, Sept. 18, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today presented updated data from the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 Europe ...

During year 5 of treatment with BRIUMVI the annualized relapse rate was 0.020, equivalent to one relapse occurring every 50 years of patient treatment Overall safety profile of BRIUMVI remained consistent over 5 years of continuous treatment, with no new safety signals emerging with prolonged treatment NEW YORK, Sept. 18, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced updated data presentations including new five-year data from the ULTIMATE I & II Phase 3 trials evaluating BR ...

NEW YORK, Sept. 05, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of upcoming data presentations, highlighting data from both the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, being held September 18 – 20, 2024, in Copenhagen, Denmark. Abstrac ...

E i i 1 E i # [ I i ■ l r l = ri i - r l = = t F l l 1 i i i = iQoncept TG Therapeutics (NASDAQ:TGTX) beat Q2 Street consensus estimates and my $67-69 million estimate range by reporting Briumvi net sales of $72.6 million and total revenues of $73.5 million. The company also achieved positive cash flow one quarter ahead of my expectations, the full-year guidance range was raised by $15 million at the mid-point, and the company secured a new $250 million credit facility to retire the existing facility with H ...

TG Therapeutics (TGTX) came out with quarterly earnings of $0.04 per share, beating the Zacks Consensus Estimate of a loss of $0.04 per share. This compares to loss of $0.34 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 200%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.03 per share when it actually produced a loss of $0.07, delivering a surprise of -133.33%. Over the last four ...