TG Therapeutics(TGTX)

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TG Therapeutics(TGTX) - 2022 Q4 - Annual Report
2023-03-01 22:21
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, 2022. 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) (State or other jurisdict ...
TG Therapeutics(TGTX) - 2022 Q4 - Earnings Call Transcript
2023-02-28 19:06
Financial Data and Key Metrics Changes - The GAAP net loss for the year ended December 31, 2022, was $198 million or $1.46 per share, a decrease from a net loss of $348 million or $2.63 per share in 2021, reflecting a year-over-year decrease of approximately $150 million due to streamlined efforts [32] - The GAAP net loss for Q4 2022 was approximately $53 million or $0.39 per share, down from a net loss of approximately $93 million or $0.70 per share in Q4 2021, driven by a disciplined spending approach [53] Business Line Data and Key Metrics Changes - BRIUMVI received FDA approval to treat adult patients with relapsing forms of multiple sclerosis (RMS), marking a significant milestone for the company [4] - The launch of BRIUMVI is focused on building awareness, driving utilization, and minimizing access barriers, with early feedback indicating significant interest from healthcare providers [10][12] Market Data and Key Metrics Changes - Approximately 35% of covered lives in the U.S. now have payer coverage for BRIUMVI, ahead of internal goals [13] - The company estimates that nearly 1 million Americans are living with MS, with 75,000 to 80,000 seeking new treatment each year, indicating a substantial market opportunity [24] Company Strategy and Development Direction - The company aims to achieve coverage for the majority of covered lives in the U.S. by the first half of 2023, with a long-term goal of reaching 80% to 90% coverage by the end of the year [75] - The company is investing in a mix of promotional resources, including in-person and virtual marketing, to support the launch of BRIUMVI [48] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early launch activities of BRIUMVI, noting that initial successes are ahead of schedule and position the company for an exciting year of commercial execution [99] - The company is focused on minimizing access barriers and achieving optimal patient access to BRIUMVI, with positive early feedback from infusion centers [50][51] Other Important Information - The company ended 2022 with approximately $220 million in cash, cash equivalents, and investment securities, including $45 million of available capacity under its Hercules facility [15] - Operating expenses for 2023 are expected to average approximately $40 million to $50 million per quarter, excluding BRIUMVI inventory build [16] Q&A Session Summary Question: What is the initial dosing protocol for patients switching from other anti-CD20 therapies? - Patients switching will go through the four-hour starting dose as per label, with a switch study planned to evaluate the necessity of this protocol [36][39] Question: What percentage of patients are utilizing patient assistance programs? - A higher percentage of patients are expected to engage with assistance programs in the first half of the year, which should decrease over time as coverage improves [42] Question: What is the company's strategy regarding the European market? - The company anticipates being six to nine months behind in the European market and is evaluating whether to partner or handle it independently [60] Question: How is the sales force currently structured? - The company feels that its sales force is appropriately sized for the current opportunity, with ongoing evaluations to ensure effectiveness [79][80] Question: What is the cash position and expected R&D and G&A mix for 2023? - The cash position at the end of Q4 2022 was $220 million, with operating expenses expected to be weighted towards SG&A rather than R&D [89]
TG Therapeutics(TGTX) - 2022 Q3 - Quarterly Report
2022-11-09 21:30
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 September 30, 2022 OR TG THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 36-3898269 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 2 Gansevoort Street, 9th Floor New York, New York 10014 ☐ TRANSITION REP ...
TG Therapeutics(TGTX) - 2022 Q2 - Quarterly Report
2022-08-09 20:01
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, 2022 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) - 2022 Q2 - Earnings Call Transcript
2022-08-08 18:24
TG Therapeutics, Inc. (NASDAQ:TGTX) Q2 2022 Earnings Conference Call August 8, 2022 8:30 AM ET Company Participants Jenna Bosco - Senior Vice President of Corporate Communications Adam Waldman - Chief Commercialization Officer Michael Weiss - Chairman, President & Chief Executive Officer Sean Power - Chief Financial Officer Conference Call Participants Ed White - H.C. Wainwright Eric Joseph - JPMorgan Matt Kaplan - Ladenburg Thalmann Mayank Mamtani - B. Riley Prakhar Agrawal - Cantor Fitzgerald Operator Gre ...
TG Therapeutics(TGTX) - 2022 Q1 - Quarterly Report
2022-05-10 20:31
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, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) Delaware 36-3898269 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 2 Ganse ...
TG Therapeutics(TGTX) - 2021 Q4 - Annual Report
2022-03-01 22:20
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, 2021. 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(TGTX) - 2021 Q4 - Earnings Call Transcript
2022-03-01 17:38
Financial Data and Key Metrics Changes - The company ended 2021 with over $350 million in cash, cash equivalents, and investment securities, strengthening its balance sheet [9][32] - Net product revenue for UKONIQ in Q4 was $2.3 million, bringing the full year 2021 net revenue to $6.5 million [33][34] - The net loss for Q4 2021, excluding noncash items, was approximately $79 million, an increase of $7 million from Q3 2021 [33][34] - The GAAP net loss for the full year 2021 was $348.1 million, compared to $279.4 million for 2020 [36] Business Line Data and Key Metrics Changes - UKONIQ saw a 14% growth in net sales in Q4, with overall demand increasing by 25% quarter-over-quarter [24][25] - The prescriber base for UKONIQ continues to grow, with 65% of new patient starts occurring in the community setting [25][26] - The company completed enrollment of approximately 165 CLL patients into the ultra V phase II trial and launched the phase III portion of that study [11] Market Data and Key Metrics Changes - The company reported strong engagement with healthcare providers regarding UKONIQ, with positive feedback on its differentiation and economic performance [25][26] - The market for ublituximab in relapsing forms of MS is seen as dynamic, with the potential for significant impact due to its clinical profile [14][30] Company Strategy and Development Direction - The company is focused on preparing for the potential launches of U2 for CLL and ublituximab for RMS in 2022 [87] - The strategy includes optimizing account segmentation and solidifying relationships in the hematology community [27] - The company aims to leverage insights from the UKONIQ launch to ensure a successful launch for U2 CLL [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of ublituximab in RMS, highlighting its low annualized relapse rate and shorter infusion time as competitive advantages [30] - The company is preparing for an upcoming ODAC meeting and is optimistic about obtaining a favorable outcome for U2 [86] - Management noted that the FDA is taking the review process seriously and is working hard to find the truth regarding the data submitted [57] Other Important Information - The company provided free drugs to about 37% of UKONIQ-treated patients through its Patient Support Program [24] - The company is actively engaging with payers to refine its pricing strategy for ublituximab [80] Q&A Session Summary Question: Can you provide more thoughts on the size of the salesforce for MS commercialization? - The salesforce is expected to be between 80 and 100 people, focusing on concentrated centers across the U.S. [41][43] Question: What are the anticipated confirmatory trials for follicular and marginal zone? - Discussions with the FDA are ongoing, and a trial design is being finalized [46] Question: Can you clarify the access data regarding neutralizing antibodies? - The data is similar to existing CD20s, with no anticipated impact on safety or efficacy [50][51] Question: What kind of evidence is the FDA looking for regarding the upcoming panel? - The company believes the FDA is looking for the truth and is reviewing the data carefully [57] Question: How will the FDA handle the new OS data submitted? - The FDA may consider the new data as a major amendment, potentially pushing the PDUFA date back [72] Question: What are the latest thoughts on the 2025 revenue guidance of $1 billion? - The guidance remains open until the outcomes of the ODAC and FDA decisions are known [63] Question: What is the strategy for the European market for MS? - A small team is evaluating the European opportunity, with timing expected to be six months post-U.S. approval [67]
TG Therapeutics (TGTX) Presents At 40th Annual J.P. Morgan Virtual Healthcare Conference
2022-01-12 20:53
J.P. Morgan Virtual 2022 Healthcare Conference January 2022 Forward Looking Safe Harbor Statement 2 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates", "expects", "plans", "believes", "intends", and similar words or phrases. Such statements involve risks and uncertainties that could cause TG Therapeutics' actual results to d ...
TG Therapeutics(TGTX) - 2021 Q3 - Quarterly Report
2021-11-08 21:16
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 September 30, 2021 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 othe ...