TG Therapeutics(TGTX)

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TG Therapeutics Provides Preliminary Fourth Quarter and Full Year 2024 Net Revenue and 2025 Anticipated Development Milestones
GlobeNewswire· 2025-01-14 12:00
Preliminary U.S. BRIUMVI fourth quarter and full year 2024 net product revenue of $103.6 million and $310 million, respectively Full Year 2025 target total global revenue of approximately $540 million, including BRIUMVI U.S. net product revenue of approximately $525 million NEW YORK, Jan. 14, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), yesterday announced preliminary U.S. net product revenue for BRIUMVI® for the fourth quarter and full year ended December 31, 2024 (unaudited), as well as ...
TG Therapeutics: Subcutaneous Briumvi Data A Key Near-Term Catalyst
Seeking Alpha· 2025-01-14 04:38
Company Performance - TG Therapeutics (NASDAQ: TGTX) was rated a buy in March 2024, with the first four quarters of sales of their multiple sclerosis drug, Briumvi, making their 2024 sales guidance seem achievable [1] Industry Focus - The company operates in the biotech industry, with a focus on trading around events such as trial results and NDA/BLA approvals [1] - The industry is regulated by the FDA, which is a key factor in the company's operations and product development [1]
TG Therapeutics to Participate in the 43rd Annual J.P. Morgan Healthcare Conference
GlobeNewswire· 2025-01-09 12:30
Presentation scheduled for Monday, January 13, 2025, at 4:30 PM PTNEW YORK, Jan. 09, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will present at the 43rd Annual J.P. Morgan Healthcare Conference. The presentation is scheduled to take place on Monday, January 13, 2025, at 4:30 PM PT. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section ...
TG Therapeutics Ranked Number One Fastest-Growing Company in North America on the 2024 Deloitte Technology Fast 500™
GlobeNewswire News Room· 2024-11-21 11:00
NEW YORK, Nov. 21, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced it ranked number one on the Deloitte Technology Fast 500™, a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies in North America, now in its 30th year. The Company’s growth between fiscal years 2020 to 2023 was fueled by BRIUMVI® revenues, which was approved to treat adult individuals with relapsing forms of multiple sclerosis in December ...
TG Therapeutics(TGTX) - 2024 Q3 - Quarterly Report
2024-11-07 21:33
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 ...
TG Therapeutics: Modest Q3 Sales Beat, Focus Shifts To Early 2025 Updates
Seeking Alpha· 2024-11-05 18:50
I publish my best ideas and top coverage on the Growth Stock Forum . If you're interested in finding great growth stocks, with a focus on biotech, consider signing up. We focus on attractive risk/reward situations and track each of our portfolio and watchlist stocks closely. To receive e-mail notifications for my public articles and blogs, please click the follow button . And to go deeper, sign up for a free trial to Growth Stock Forum.TG Therapeutics, Inc. (NASDAQ: TGTX ), aka TG, reported a small revenue ...
TG Therapeutics Posts Strong Q3 Briumvi Revenue, Here's Why Shares Fell
Seeking Alpha· 2024-11-05 01:27
I'm an investment analyst with several years of clinical experience and a Master of Business Administration, now expanding my focus beyond biotech and healthcare into a range of sectors. I've had the privilege of sharing my insights on Seeking Alpha since 2017. Outside of spending time with my family, it is my favorite thing to do. My work emphasizes financial modeling techniques, such as Discounted Cash Flow (DCF) analysis, to uncover hidden assumptions within stock valuations across multiple industries. B ...
TG Therapeutics(TGTX) - 2024 Q3 - Earnings Call Transcript
2024-11-04 16:16
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) Lags Q3 Earnings Estimates
ZACKS· 2024-11-04 14:10
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, ...
TG Therapeutics(TGTX) - 2024 Q3 - Quarterly Results
2024-11-04 12:19
Exhibit 99.1 TG Therapeutics Reports Third Quarter 2024 Financial Results and Raises BRIUMVI® (ublituximab-xiiy) Full Year Revenue Guidance Third quarter 2024 U.S. BRIUMVI net revenue of $83.3 million Raises full year 2024 U.S. BRIUMVI net revenue target to $300 - $305 million Conference call to be held today, November 4, 2024, at 8:30 AM ET New York, NY, (November 4, 2024) – TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) today announced its financial results for the third quarter of ...