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#NASDAQ:TGTX

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
TG Therapeutics reported strong financial performance for 2024, driven by the success of BRIUMVI, a treatment for relapsing multiple sclerosis. The company achieved $103.6 million in U.S. net revenue for BRIUMVI in the fourth quarter and $310 million for the full year, reflecting significant growth. It set a 2025 revenue target of approximately $540 million, with $525 million expected from BRIUMVI sales in the U.S.

Key developments include the expansion of BRIUMVI’s patent protection through 2042, its commercial launch in Europe, and promising five-year data showing sustained efficacy and safety. Clinical trials for a subcutaneous version of BRIUMVI and its application for autoimmune diseases are underway. The company also entered a licensing agreement for an allogeneic CD19 CAR T therapy.

Financially, TG Therapeutics reported net product revenue of $313.7 million for 2024, a significant increase from $92 million in 2023. Net income was $23.3 million for the year, compared to $12.7 million in 2023. Research and development expenses rose to $94.3 million due to new trials and licensing costs. The company ended 2024 with $311 million in cash and investment securities, expecting this to support ongoing operations.

A conference call was scheduled for March 3, 2025, to discuss these results. The company remains focused on expanding BRIUMVI’s reach, developing new treatment options, and achieving key clinical milestones in 2025.