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- **Revenue Growth**: Q3 U.S. BRIUMVI sales of $153 million (+93% YoY), full-year guidance raised to $585 million.
- **Pipeline Momentum**: Subcu ublituximab could double CD20 market; ENHANCE study on track for 2027 launch.
- **Financial Strength**: $390 million net income, $178 million cash, and $200 million share buyback program completed/authorized.
- **Strategic Focus**: DTC campaigns driving awareness, subcu product expansion, and disciplined capital allocation.

**【CEO Summary Section】**
- BRIUMVI achieved strong Q3 performance with U.S. net sales of $153 million, driving total revenue growth of 93% YoY and 15% QoQ. 
- Launched two pivotal studies: ENHANCE (simplified dosing schedule) and subcutaneous ublituximab (self-administered option). ENHANCE enrollment completed ahead of schedule, with potential data in mid-2026 and launch in 2027. Subcu ublituximab could expand the CD20 market by nearly doubling the addressable patient population.
- Completed $100 million share repurchase program, with another $100 million authorized, reflecting financial discipline and shareholder return focus.

**【Commercial Update (Adam Waldman)】**
- BRIUMVI U.S. net sales reached $153 million in Q3, exceeding internal and Street expectations. Full-year guidance raised to $585 million (from $575 million), reflecting 14% QoQ growth in Q4.
- Market penetration strengthened with 90% of patients relapse-free after 6 years of treatment, and 0.012 annualized relapse rate. Subcu ublituximab could capture 35-40% of new starts, potentially doubling the CD20 market.
- Direct-to-consumer (DTC) campaigns drove brand awareness and patient engagement, with encouraging early metrics on search volume and website traffic.

**【Financial Highlights (Sean Power)】**
- Q3 GAAP net income of $390.9 million ($2.43 EPS), driven by BRIUMVI revenue growth and a $365 million tax benefit from deferred tax asset release.
- Total revenue $161.7 million (93% YoY growth), with product revenue $159.3 million. Operating expenses $86.6 million, on track for $300-320 million annual guidance.
- Cash balance of $178 million, supporting long-term pipeline investments and strategic flexibility.

**【Q&A Highlights】**
- **Market Dynamics**: Subcu segment accounts for ~35-40% of new starts, with BRIUMVI maintaining leadership in IV market. DTC campaigns expected to accelerate new patient growth in 2026.
- **Pipeline Progress**: Subcu ublituximab pivotal data anticipated in late 2026/early 2027, with potential launch in 2028. ENHANCE simplified dosing regimen could enhance patient convenience and adherence.
- **Financial Strategy**: No immediate M&A plans, prioritizing organic growth and shareholder returns. 2026 guidance to be provided in Q1 2026, with focus on BRIUMVI persistence rates and pipeline milestones.

TG Therapeutics, Inc. (TGTX) Q3 2025 Earnings Call Transcript

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