TG Therapeutics (TGTX) investor relations material

Business overview and key priorities

• Focused on commercial execution for BRIUMVI, approved for relapsing MS, with 2024 U.S. revenue guidance of $885–$900 million.

• Positive ENHANCE study readout may lead to a label change in 2027, simplifying onboarding.

• Subcutaneous (sub-Q) program showed positive data, targeting a new product launch in 2028.

• Initiated a phase II study in myasthenia gravis (MG) following promising phase I results.

• Ongoing focus on expanding indications and optimizing patient experience.

Clinical development and study design

• Phase I sub-Q study in MG showed strong confirmation of effect in 11 patients, supporting further development.

• Phase II MG study designed to maintain clinical benefit post-FCARD run-in, using standard BRIUMVI dosing.

• Study aims to demonstrate sustained benefit versus placebo, using a time-to-event analysis.

• FDA has reviewed the trial; registration potential will depend on data outcomes.

Commercial performance and market dynamics

• BRIUMVI benefits from high patient persistence, with a median treatment course modeled at five years.

• Market share in IV CD20 class is approaching one-third, translating to about 20% overall share.

• Revenue run rate expected to surpass $1 billion before the end of the fourth year of sales.

• Peak opportunity for IV business projected to be multiples above current levels, with years of growth ahead.