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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