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• US Net Sales for BRIUMVI: Approximately $119.7 million in Q1 2025, reflecting 137% year-over-year growth and 16% sequential quarter-over-quarter growth.

• Full Year 2025 US Net Revenue Guidance: Increased from $525 million to $560 million.

• Operating Expenses (OpEx): Approximately $82 million for the quarter, driven by $20 million in manufacturing investments for subcutaneous BRIUMVI.

• Full Year OpEx Guidance: Approximately $300 million.

• GAAP Net Income: Approximately $5 million or $0.03 per diluted share for Q1 2025.

• Cash Position: $276 million in cash, cash equivalents, and investment securities at the end of Q1 2025.

• Warning! GuruFocus has detected 8 Warning Signs with TGTX.

Release Date: May 05, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• BRIUMVI US net sales reached nearly $120 million in the first quarter, exceeding expectations.

• The company reported a 137% year-over-year growth and 16% sequential quarter-over-quarter growth in BRIUMVI sales.

• Positive real-world experiences and publications support BRIUMVI's efficacy and tolerability, driving patient and prescriber confidence.

• The company is advancing its pipeline with initiatives like a self-administered subcutaneous BRIUMVI and azer-cel, a CD19 CAR-T cell therapy.

• TG Therapeutics Inc (NASDAQ:TGTX) increased its full-year 2025 US net revenue guidance for BRIUMVI from $525 million to $560 million.

Negative Points

• Operating expenses, excluding noncash items, were approximately $82 million for the quarter, slightly ahead of full-year guidance.

• The company faces a highly competitive market, particularly from other anti-CD20 therapies.

• Potential tariffs on BRIUMVI, manufactured in South Korea, could impact financial performance, though the company is monitoring the situation.

• The North Carolina manufacturing facility is not expected to produce commercial-scale products for several years.

• The company is not currently focused on profitability, with no specific earnings per share guidance provided.

Q & A Highlights

Q: Can you provide more color on competitive dynamics, especially with Ocrevus de novo, and what you're seeing with new patient share? A: Adam Waldman, Chief Commercialization Officer: We saw the highest three months ever on patient enrollments and a strong month in April, indicating continued market share gains. We believe we're getting about 25% of the IV segment, and we haven't seen any impact from de novo on BRIUMVI.

Q: Any update on gross to net trends this quarter and how the Part D redesign may have affected this? Also, when can we expect you to fully deplete the prelaunch reserves in gross margin? A: Adam Waldman, Chief Commercialization Officer: No material change in gross to net this quarter, and Part D redesign is not relevant for our drug. Sean Power, CFO: We have fully depleted the pre-commercial inventory reserve, so margins will be consistent going forward.