TG Therapeutics raises full-year BRIUMVI revenue guidance after strong Q1 growth
• Q1 2025 BRIUMVI U.S. net revenue: $119.7 million (up ~137% YoY)
• Q1 2025 Total revenue: $120.9 million (up from $63.5 million YoY)
• Q1 Net income: $5.1 million vs. net loss of $10.7 million in Q1 2024
• R&D expense: $46.4 million (up from $32.7 million)
• SG&A expense: $50.3 million (up from $34.6 million)
• Cash and equivalents: $276.2 million as of March 31, 2025
Updated 2025 Guidance:
• BRIUMVI U.S. net revenue: Raised to $560 million (from $525 million)
• Global revenue: Raised to $575 million (from $540 million)
• Q2 2025 U.S. net revenue target: $135 million
• Operating expense (excluding COGS and non-cash comp): ~$300 million
• Cash position expected to support operations under current plan
Product & Pipeline Developments:
• BRIUMVI now available in additional European markets via partner Neuraxpharm
• Five-year ULTIMATE I & II extension data showed:
o 92% of patients free from disability progression
o Annualized relapse rate of 0.02 in year 5
o No new safety signals or PML cases
• ENHANCE Phase 3b trial data supported simplified dosing regimens and rapid 30-minute infusions
• Pipeline milestones:
o Subcutaneous BRIUMVI pivotal program to commence
o Pivotal trial for improved IV dosing regimen to launch
o Enrollment underway for trials in myasthenia gravis and progressive MS with BRIUMVI and azer-cel