The following is a summary of the TG Therapeutics, Inc. (TGTX) Q3 2024 Earnings Call Transcript:

Financial Performance:

• TG Therapeutics reported Q3 BRIUMVI U.S. net sales of $83.3 million, with a quarter-over-quarter growth of approximately 15% and a 230% increase from the same quarter last year.

• BRIUMVI net product revenue for the nine months of 2024 reached $206.4 million.

• GAAP net income for Q3 was approximately $3.9 million or $0.02 per diluted share. Excluding non-cash items, net income was about $15.7 million.

Business Progress:

• Positive clinical trial results and strong market feedback on BRIUMVI, highlighted by long-term data showing 92% of patients free from disability progression after five years and an annualized relapse rate of 0.02.

• Introduced potential 30-minute infusion update of BRIUMVI, enhancing patient convenience and treatment efficiency.

• Established FUJIFILM Diosynth Biotechnologies as a second manufacturer for BRIUMVI to manage supply risk and support growth.

• Developing a subcutaneous (subcu) version of BRIUMVI to cater to the at-home treatment market, with plans for a pivotal trial in 2025.

• Initiating a Phase 1 study for azer-cel, an allogeneic CD19 CAR T-cell therapy for autoimmune diseases, focusing initially on progressive MS.

Opportunities:

• The expansion of commercial infrastructure and patient awareness campaigns to boost BRIUMVI adoption.

• Continued growth and market share increase in the MS treatment space, with BRIUMVI positioned as a preferred anti-CD20 therapy due to its compelling efficacy and safety profile.

Risks:

• Potential challenges in clinical trial enrollments for new infusion protocols and subcutaneous versions that could delay product enhancements and market introductions.

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