Earning Date, Transcript Summary & Report

Earnings Surprise: TG Therapeutics, Inc. beats earnings expectations with reported EPS of $0.15, exceeding expectations of $0.08.

U.S. Revenue Achievement: Full year 2024 U.S. revenues reached $310 million, significantly surpassing target guidance and reflecting the value of BRIUMVI for MS patients.

Safety and Tolerability Profile: BRIUMVI demonstrated a consistent safety and tolerability profile with over 80 patients treated in the 30-minute infusion cohort, as presented at the ACTRIMS Conference.

Long-term Efficacy Results: Five-year follow-up data from the ULTIMATE I and II trials showed 92% of patients were free from disability progression, with an annualized relapse rate of 0.02, indicating long-term efficacy.

Patent Protection Extension: TG Therapeutics received three new patents for BRIUMVI, extending patent protection through 2042, which strengthens their market position.

International Launch Momentum: BRIUMVI's international launch is gaining momentum, with positive feedback from the EU following its launch in Germany and other countries.

Subcutaneous BRIUMVI Development: The company is developing a subcutaneous formulation of BRIUMVI, which could potentially reduce the number of injections per year, enhancing patient convenience.

Exploratory Study Initiation: TG Therapeutics has initiated an exploratory study for treating Myasthenia Gravis with BRIUMVI, indicating expansion into new therapeutic areas.

Strategic CAR-T Partnership: The partnership with Precision BioSciences to develop azer-cel for autoimmune diseases represents a strategic growth opportunity in the CAR-T therapy market.

Controlled Operating Expenses: Operating expenses for 2024 were well controlled at approximately $206 million, below guided ranges, contributing to a GAAP net income of $23 million.

Operating Expenses Impact Profitability: Despite beating earnings expectations, the company reported a significant increase in operating expenses, which could impact future profitability.

Gross Margin Challenges: The gross margin was negatively affected by the cost of goods sold to Neuraxpharm, indicating potential challenges in maintaining profitability on international sales.

Market Competition Challenges: The company faces competition from new entrants in the market, which could hinder BRIUMVI's growth and market share.

U.S. Market-Driven Growth Concerns: While the revenue growth was strong, it was primarily driven by the U.S. market, raising concerns about the sustainability of growth in international markets.

Product Dependency Risk: The reliance on a single product, BRIUMVI, for the majority of revenue poses a risk if market dynamics change or if the product faces regulatory challenges.