TG Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total global revenue for Q3 2026 was approximately $260 million ($259.9 million), compared to $161.7 million in Q3 2025.
• Product revenue, net for Q3 2026 was $240.0 million, up from $159.3 million in Q3 2025.
• BRIUMVI U.S. net product revenue for Q3 2026 was $232.6 million, representing a 52% increase year-over-year.
• License, milestone, royalty, and other revenue for Q3 2026 was approximately $19.9 million, compared to $2.4 million in Q3 2025.
• Net income for Q3 2026 was $55.5 million, compared to $390.9 million in Q3 2025; the prior year figure included a non-recurring income tax benefit of approximately $365.0 million.
• Operating income for Q3 2026 was $85.9 million, compared to $29.4 million in Q3 2025.
• R&D expenses for Q3 2026 were approximately $51.3 million, compared to $40.9 million in Q3 2025.
• SG&A expenses for Q3 2026 were approximately $80.7 million, compared to $63.4 million in Q3 2025.
• Cash, cash equivalents, and investment securities totaled $556.7 million as of September 30, 2026, compared to $199.5 million as of December 31, 2025.

Guidance and Future Outlook:

• Raised full-year 2026 total global revenue guidance to approximately $1 billion, from approximately $950 million.
• Raised full-year 2026 BRIUMVI U.S. net product revenue guidance to approximately $915–920 million, from $890–905 million.
• Reaffirmed full-year 2026 operating expense guidance (R&D and SG&A excluding non-cash compensation) of approximately $450–500 million.
• Anticipates top-line Phase 3 data for subcutaneous BRIUMVI by year-end 2026 or early 2027.
• Management expects a potential launch of simplified IV initiation in mid-2027 and a potential subcutaneous BRIUMVI launch in 2028.
• Management stated that cash and projected revenues are sufficient to fund the business based on the current operating plan.

Business Segments and Product Lines:

• BRIUMVI U.S. net product revenue grew 52% year-over-year in Q3 2026.
• Sales of BRIUMVI to ex-U.S. licensing partner Neuraxpharm were $7.4 million in Q3 2026, compared to $6.4 million in Q3 2025.
• Initiated a Phase 2 clinical trial evaluating BRIUMVI in adults with treatment-resistant schizophrenia.
• Initiated a potentially registration-directed Phase 2 clinical trial evaluating IV BRIUMVI as maintenance therapy in adult patients with myasthenia gravis (MG) following induction with efgartigimod.
• Announced positive topline Phase 1 data for subcutaneous BRIUMVI in patients with MG.
• Presented Phase 1 data for Azer-cel in progressive MS showing an encouraging safety profile in 26 participants.

Market and Competitive Landscape:

• BRIUMVI demonstrated sustained efficacy in seven-year follow-up data from ULTIMATE I & II Phase 3 trials, with an annualized relapse rate (ARR) of 0.018 in the seventh year.
• 88.3% of continuously treated patients in the seven-year follow-up remained free from 24-week confirmed disability progression.
• Phase 4 ENABLE Real-World Study data from 1,076 participants showed 99.2% remained relapse-free during BRIUMVI treatment with an ARR of 0.014.
• Phase 3 ENHANCE Trial results demonstrated bioequivalent drug exposure between the current two-infusion initiation regimen and a consolidated single 600mg initiation infusion.
• Phase 1 Subcutaneous BRIUMVI trial data showed mean bioavailability greater than 60% relative to IV administration, supporting a quarterly dosing regimen.

Risks and Challenges:

• Forward-looking statements involve risks including the ability to continue commercializing BRIUMVI, maintaining prescription trends, and obtaining/maintaining payor coverage.
• Risks include potential failure to obtain regulatory approvals, variations in market projections, and delays in clinical trial data readouts.
• Specific risks involve the success and approval of subcutaneous BRIUMVI, the ENHANCE Phase 3 trial, and development of BRIUMVI in MG, schizophrenia, and Azer-cel.
• Safety warnings include infusion reactions, serious infections, Hepatitis B reactivation, Progressive Multifocal Leukoencephalopathy (PML), and liver injury.
• Reliance on third parties for manufacturing, distribution, and supply functions poses a risk to meeting market demand.

Management Commentary and Tone:

• CEO Michael S. Weiss stated the company is on track to exceed $1 billion in global revenue in 2026, less than four years after launching BRIUMVI.
• Management expressed confidence in sustained, long-term growth driven by IV business momentum, new dosing options, and an expanding pipeline.
• Weiss highlighted a series of important catalysts over the next 18 to 24 months, including subcutaneous BRIUMVI results and simplified IV initiation.
• Management noted that the $100 million in shares repurchased during the quarter underscores confidence in TG's long-term value.

Other Key Points:

• Repurchased approximately $100 million of TGTX common stock in Q3 2026 (2.0 million shares at an average price of $49.43 per share).
• Through the end of Q3 2026, the company has repurchased a total of $300 million of TGTX common stock (8.9 million shares, or approximately 6% of shares outstanding).
• Conference call scheduled for November 9, 2026, at 8:30 AM ET.
• BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.