Workflow
TG Therapeutics(TGTX)
icon
Search documents
TG Therapeutics(TGTX) - 2019 Q1 - Earnings Call Transcript
2019-05-10 21:03
Financial Data and Key Metrics Changes - The company reported a net loss of approximately $33.3 million for Q1 2019, compared to a net loss of $41.5 million in Q1 2018, representing a decrease in loss of about 19% [10] - GAAP net loss for Q1 2019 was $35.2 million, or $0.43 per share, down from $0.59 per share in the same quarter of the previous year [10] - Cash position improved to $92.5 million as of March 31, 2019, with a pro forma cash position of approximately $116.7 million after additional fundraising [9][10] Business Line Data and Key Metrics Changes - Significant progress was made in the Marginal Zone Lymphoma (MZL) program, with positive top-line results and breakthrough designation from the FDA [13][14] - The UNITY-NHL Phase 2b pivotal trial of umbralisib monotherapy in MZL showed an overall response rate that met the study's primary endpoint [20] - The company is optimistic about the potential for accelerated approval filing for MZL by year-end [21] Market Data and Key Metrics Changes - The market for CD20 therapies in multiple sclerosis (MS) is projected to be substantial, with ofatumumab expected to generate approximately $4 billion in revenue in 2019 [29] - The company aims to capture a significant share of the market for B-cell cancers, with a focus on providing non-chemotherapy options [52] Company Strategy and Development Direction - The company plans to focus resources on the MZL data preparation for potential filing, while also preparing for future trials in CLL and follicular lymphoma [38] - The strategy includes building a robust commercial team to support the launch of umbralisib and U2 [89] - The company is developing a pipeline of early clinical drug candidates, including TG-1501, TG-1701, and TG-1801, with potential pivotal trials in 2020 [30][63] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing trials and the potential for successful outcomes, particularly in the UNITY-CLL study [24][50] - The company is focused on obtaining clarity from the FDA regarding the regulatory path for MZL and aims to present final data by year-end [95] - There is a strong belief that umbralisib offers a more attractive profile for patients compared to existing therapies, which could lead to significant market opportunities [52] Other Important Information - The company has received orphan drug designation for umbralisib for the treatment of MZL, enhancing its market position [18] - Positive interim data from the MS program was presented, showing ublituximab's well-tolerated profile with a median follow-up of 97.5 weeks [26] Q&A Session Summary Question: Can you discuss the timelines for the NHL study and the follow-up needed? - Management believes they can file for accelerated approval by year-end with a good nine months of follow-up on all patients, even if the FDA requests 12 months [35][36] Question: What is the confidence level regarding the PFS timeline? - Management stated that the control arm's performance is well-known, and they expect to see a 40% to 50% improvement in PFS, with the study potentially concluding by the end of the year [50][51] Question: How does the company view the competitive landscape for MZL? - Management feels confident about the path to approval for umbralisib, emphasizing the need for non-chemotherapy options in MZL treatment [52] Question: What are the commercialization plans for Marginal Zone in the U.S.? - The company plans to build a strong commercial team to effectively launch umbralisib and U2, leveraging available talent in the market [89] Question: What feedback has been received from physicians regarding MS therapies? - Positive feedback was received at AAN, with enthusiasm for the one-hour infusion of ublituximab noted as a significant advantage [71][72]
TG Therapeutics (TGTX) Presents At AACR Annual Meeting 2019 - Slideshow
2019-04-01 20:30
1 2019 American Association of Cancer Research (AACR) Data Review Call April 1, 2019 Forward Looking Statements 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' actua ...
TG Therapeutics(TGTX) - 2018 Q4 - Annual Report
2019-03-01 21:48
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, 2018. 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 (State or other jurisdiction of in ...