Workflow
TG Therapeutics (NasdaqCM:TGTX) FY Conference Transcript
TG TherapeuticsTG Therapeutics(US:TGTX)2025-09-08 15:32

TG Therapeutics FY Conference Summary Company Overview - Company: TG Therapeutics (NasdaqCM:TGTX) - Focus: Development and commercialization of therapies for relapsing multiple sclerosis (MS) and other autoimmune diseases Industry Context - Market Size: Approximately 1 million individuals in the US have relapsing forms of MS, with 300,000 to 400,000 treated annually. About 80,000 patients seek new treatments each year [3][4] - Treatment Landscape: The anti-CD20 monoclonal antibody class includes three drugs, with TG Therapeutics' product, Brionvy, being one of them. The market is competitive, with a significant portion of patients switching therapies frequently [4][5] Key Points and Arguments Product Differentiation - Administration Options: Brionvy is administered intravenously (IV), while competitors offer both IV and subcutaneous (subcu) options. Approximately 35% to 40% of patients prefer subcu options, while 65% choose IV [6][9] - Infusion Time: Brionvy has a one-hour infusion time compared to competitors' two to three and a half hours, potentially offering significant time savings for patients [8][9] - Cost Advantage: Brionvy is priced 20% to 25% lower than its main competitor, which may influence clinician choice [9] Revenue Guidance and Market Penetration - 2025 Revenue Guidance: Projected revenue for 2025 is between $5.70 billion and $5.75 billion, driven by new start forms and patient persistence on therapy [10][12] - Market Share: Brionvy is approaching a 33% market share in the IV segment, up from 25% at the beginning of the year [17][18] Patient Demographics - Switching Patterns: The majority of patients starting on Brionvy are switching from other therapies, not just other anti-CD20 treatments [19][20] Real-World Efficacy - Patient Experience: Anecdotal evidence suggests that patients on Brionvy are experiencing good outcomes, with lower rates of infusion-related reactions (IRRs) compared to competitors [21][24][25] Commercialization Strategy - Launch Approach: TG Therapeutics has focused on educating clinicians before direct-to-patient marketing. Recently, they launched a TV commercial to increase patient awareness [28][29] - International Plans: The company has partnered with Nurax Farm for ex-US commercialization, but expects US sales to dominate overall revenues [30][31] Development Pipeline - Subcutaneous Formulation: Enrollment for a pivotal trial for a subcu formulation has begun, with potential approval expected in 2028 [37][38] - Other Indications: The company is exploring the use of Brionvy in myasthenia gravis (MG) but has not committed to moving forward yet [44][46] - CAR T Development: TG Therapeutics is also developing a CD19 CAR T therapy, with ongoing trials in progressive MS [47][50] Upcoming Milestones - Revenue Updates: Anticipated revenue surprises as the company updates forecasts [54] - Data Releases: ENHANCE data expected in 2026, subcu data in 2027, and potential updates on the CAR T program [55][56] Additional Insights - Market Opportunity: The company aims to capture a significant share of the subcu market currently dominated by competitors [42][43] - Patient Enrollment: Expansion of protocols to include various MS types and other indications is planned [51][52]