TG Therapeutics(TGTX)2024-11-04 16:16Financial Data and Key Metrics - Q3 2024 BRIUMVI US net sales were 206.4 million [35] - GAAP net income for Q3 2024 was approximately 0.02 per diluted share, while non-GAAP net income was 50 million, and full-year OpEx is expected to be below the guidance of 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 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]