TG Therapeutics (TGTX) investor relations material

Market landscape and commercial performance

• Relapsing multiple sclerosis sees about 40,000 new patients annually, with 65%-70% opting for IV therapies and 30%-35% for subcutaneous options.

• The IV segment is growing, with over one-third market share and consistent outperformance of sales guidance, targeting a $1 billion run rate by year-end.

• Key revenue drivers are new patient starts and persistence, with gross-to-net fluctuations impacting quarterly results.

• Patient distribution among naive, non-CD20, and CD20-switchers is now nearly equal, with naive patient uptake increasing over time.

• Shared decision-making is prevalent, with patients choosing between self-injection and infusion based on preference.

Product development and competitive positioning

• Enhanced dosing protocol consolidating initial doses is expected to simplify administration and drive growth in 2027.

• Supplemental BLA for the enhanced protocol is imminent.

• Subcutaneous formulation phase I data showed over 60% bioavailability, supporting confidence for phase III, with pivotal data expected late 2024 or early 2025.

• Quarterly auto-injector is positioned as highly competitive versus monthly or bimonthly alternatives.

• Ex-U.S. commercialization is progressing well, especially in markets where subcutaneous options dominate over 50% of share.

Industry trends and future outlook

• IV and subcutaneous markets are both seen as having significant growth potential, with subcutaneous possibly surpassing IV.

• OCREVUS patent expiry in 2028 and competitor moves to on-body injectors are being monitored.

• Oral BTK inhibitors are expected to have minimal impact on the anti-CD20 market, which retains about 50%-55% dynamic share.

• Upcoming catalysts include supplemental BLA approval, phase III subcutaneous data, schizophrenia trial results, and potential 2028 subcutaneous approval.