TG Therapeutics(TGTX) - 2024 Q4 - Annual Report

Financial Performance - Company generated net income recently but has incurred significant operating losses since inception, indicating potential future losses[17] - Company’s financial performance and cash burn management are critical for sustaining operations[17] - Company is subject to various risks including regulatory changes, competition, and market acceptance that could adversely affect financial performance[14] Regulatory Approval and Commercialization - Company anticipates maintaining regulatory approval for BRIUMVI® (ublituximab) for the treatment of relapsing forms of multiple sclerosis (RMS) in the U.S., EU, and UK[13] - Company is focused on obtaining regulatory approvals for product candidates, including BRIUMVI® (ublituximab) for relapsing forms of multiple sclerosis, with ongoing efforts to adapt commercial infrastructure[13] - Company is focused on expanding its commercial infrastructure to market and sell BRIUMVI and other product candidates[13] - Company anticipates ongoing commercialization efforts for BRIUMVI, with expectations for market acceptance and pricing strategies[13] Capital and Funding - Company may need to raise additional capital in the future, which could delay or limit drug development programs[17] - Company’s ability to maintain and establish collaborations is essential for funding and commercializing drug products[20] - Company is dependent on collaborations and partnerships for further development and commercialization of its drug products[20] Competition and Market Risks - Company faces substantial competition that may impact its ability to commercialize drugs successfully[17] - Company faces substantial competition which may impact the commercialization of its drugs, potentially reducing revenue opportunities[17] - Company’s stock price is expected to remain volatile, affecting investors' ability to sell shares profitably[20] - Company’s stock price is expected to remain volatile, which may affect investors' ability to sell shares profitably[20] Operational Risks - Company relies on third parties for clinical trials and manufacturing, increasing risks related to product supply and quality[20] - Company has identified a material weakness in internal control over financial reporting, which has been remediated[20]