TG Therapeutics(US:TGTX)2025-03-03 16:55Financial Data and Key Metrics Changes - For the full year 2024, U.S. revenues reached $310 million, exceeding target guidance and reflecting a 250% growth compared to 2023 [9][25] - Fourth quarter U.S. net sales for BRIUMVI were $103.6 million, representing a 24% growth quarter-over-quarter and 160% growth year-over-year [25][36] - Total global revenue for 2024 was approximately $329 million, including $310 million from U.S. BRIUMVI net product sales and $12.5 million milestone from a partner [36] Business Line Data and Key Metrics Changes - BRIUMVI's performance in the U.S. market showed significant growth, with strong demand leading to above-expectation revenues [25][29] - The company reported a gross margin impacted by lower margins on products sold to partners, but overall gross margin is expected to remain consistent [38] Market Data and Key Metrics Changes - BRIUMVI is gaining momentum internationally, with successful launches in Germany and other EU countries, receiving positive feedback [26] - The company is focusing on expanding its market share in the relapsing MS market, with a goal to reach more eligible patients [30] Company Strategy and Development Direction - The company plans to launch pivotal trials for a subcutaneous formulation of BRIUMVI and explore its use in other autoimmune diseases [19][20] - A partnership with Precision BioSciences was established to develop azer-cel for autoimmune diseases, indicating a strategic expansion into CAR-T therapies [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of BRIUMVI, supported by strong early performance in 2025 and a robust commercial infrastructure [30][32] - The company anticipates multiple drivers for growth in 2025, including deeper penetration in the RMS market and increased patient education efforts [30][31] Other Important Information - The company received three new patents for BRIUMVI, extending patent protection through 2042 [22] - The company ended the fourth quarter with approximately $311 million in cash, providing a strong financial position for future investments [40] Q&A Session Summary Question: Insights on growth and market segments - Management noted that growth is coming from a broad set of customers, particularly in academic hospitals, and January and February showed strong enrollment trends [48][49] Question: Subcutaneous trial design and expectations - The subcutaneous trial design is not finalized, but the target is to commence by mid-year, with expectations of a gross-to-net range of 70% to 75% [54][58] Question: Size and timing of the subcutaneous trial - The trial size is expected to be similar to Ocrevus' subcutaneous studies, with an enrollment period projected to be around 12 months [63] Question: Feedback on ENHANCE trial data - Feedback from the ACTRIMS conference indicated that many physicians are already comfortable switching patients to BRIUMVI without the introductory dose, although formal label changes are still pending [80][82] Question: Myasthenia gravis expansion opportunity - Management is exploring the potential for BRIUMVI in treating myasthenia gravis, noting that while the market is not underserved, there is room for effective and cost-efficient treatments [85][87]