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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call summary highlights strong financial performance with significant growth in revenue and net income. The company's strategic initiatives, like the development of subcutaneous BRIUMVI and market expansion efforts, are promising. The Q&A section reveals optimism about future growth, despite some uncertainties in competitive dynamics and lack of specific guidance for 2026. The raised revenue guidance and strong market share growth for BRIUMVI further support a positive outlook. Overall, these factors suggest a likely positive stock price movement in the short term.
Total Revenue $161.7 million, an increase of 93% compared to Q3 '24 and 15% over Q2 '25. The increase was driven by strong commercial performance, particularly from BRIUMVI sales.
Product Revenue $159.3 million, primarily driven by $152.9 million in U.S. BRIUMVI net sales.
U.S. BRIUMVI Net Sales $152.9 million, reflecting strong sequential and year-over-year growth. The growth was attributed to sustained physician engagement, increasing patient awareness, and positive real-world experiences.
Operating Expenses (R&D and SG&A) $86.6 million in Q3, up from $71 million in Q2 '25. The increase was due to continued investment in R&D for subcutaneous BRIUMVI and higher SG&A spend to support the commercial expansion of BRIUMVI.
Cash, Cash Equivalents, and Investment Securities $178 million as of the end of Q3 '25, reflecting a strong capital position after completing a $78 million share repurchase program.
GAAP Net Income $390.9 million or $2.43 per diluted share for Q3 '25, compared to $3.9 million or $0.02 per diluted share in Q3 '24. This includes a nonrecurring income tax benefit of approximately $365 million due to the release of a deferred tax asset valuation allowance.
BRIUMVI for relapsing MS: Continues to outperform expectations with U.S. net sales of $153 million in Q3 2025. The product has shown strong sequential and year-over-year growth, exceeding internal and market expectations. It is supported by favorable dynamics such as strong demand, physician engagement, and increasing patient awareness.
ENHANCE pivotal study: Aims to consolidate BRIUMVI's day 1 and day 15 doses into a single day 1 infusion. Enrollment is complete, and data is expected by mid-2026, with a potential launch in 2027.
Phase III subcutaneous ublituximab study: Testing self-administration options with two dosing schedules. Enrollment is progressing well, with data expected in late 2026 or early 2027 and potential approval in 2028.
Azer-cel CAR T therapy: In early development for progressive MS, with potential to be life-changing for patients.
Market expansion for BRIUMVI: The anti-CD20 class now represents nearly $10 billion in annual U.S. MS sales, with significant opportunity remaining as approximately half of patients are still on other therapies. BRIUMVI is positioned to become a multibillion-dollar brand in RMS.
Subcutaneous ublituximab: Expected to nearly double the total addressable market for BRIUMVI, providing a unique competitive advantage by offering both IV and self-administered CD20 options.
Financial performance: Total revenue reached $161.7 million in Q3 2025, a 93% increase compared to Q3 2024. Operating expenses are on track with full-year guidance, and the company reported its sixth consecutive quarter of profitability.
Share repurchase program: Completed a $100 million share repurchase program, buying back 3.5 million shares at an average price of $28.50. A new $100 million program has been authorized.
Strategic focus on innovation: Continued investment in R&D for subcutaneous BRIUMVI and azer-cel CAR T therapy, aiming for meaningful new launches in 2027, 2028, and 2029.
Marketing and awareness campaigns: Launched a national television campaign and expanded digital and social media initiatives to drive patient engagement and brand awareness for BRIUMVI.
Regulatory Risks: The discussion includes forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially. These risks are detailed in SEC filings, indicating potential regulatory hurdles.
Strategic Execution Risks: The company is pursuing multiple pivotal studies and product launches, including ENHANCE and subcutaneous ublituximab, which involve complex execution and timelines. Delays or failures in these initiatives could impact strategic objectives.
Market Competition: The anti-CD20 class represents a $10 billion market, but competitive pressures exist as other companies also target this space. TG Therapeutics aims to differentiate with both IV and self-administered options, but competition remains a challenge.
Financial Discipline and Investment Risks: The company has chosen to stay patient with capital deployment, avoiding potentially tempting deals. However, this conservative approach could limit growth opportunities if not balanced effectively.
Supply Chain and Operational Risks: Expansion of the commercial field organization and increased SG&A spending to support BRIUMVI's growth could strain operational efficiency if not managed carefully.
Revenue Guidance: The company raised its full-year 2025 U.S. BRIUMVI net revenue guidance from $570-$575 million to approximately $585 million, reflecting favorable demand trends and consistent execution by the commercial team.
Future Product Launches: The company anticipates meaningful new product launches in 2027, 2028, and 2029, which are expected to drive continued growth into the next decade.
ENHANCE Study: The ENHANCE study aims to simplify BRIUMVI dosing by consolidating the day 1 and day 15 doses into a single day 1 infusion. Data is expected by mid-2026, with a potential launch of the new dosing schedule in 2027.
Subcutaneous Ublituximab Study: The Phase III subcutaneous ublituximab study is testing two dosing schedules (every other month and quarterly). Enrollment is expected to complete in the first half of 2026, with top-line data anticipated in late 2026 or early 2027. If successful, approval and launch are targeted for 2028.
Market Expansion: Subcutaneous ublituximab is expected to nearly double the total addressable market for BRIUMVI. If approved, TG Therapeutics would be the only company offering both IV and self-administered CD20 options, providing a competitive advantage.
Azer-cel Development: The company is developing azer-cel, an allogeneic CAR T therapy for progressive MS, which could be life-changing for patients. This is an early-stage development with no specific timeline provided.
Financial Discipline: The company remains operationally profitable and expects this trend to continue, barring any one-time business development moves that could temporarily impact the financial picture but strengthen it in the long term.
Share Repurchase Program: During the quarter, TG Therapeutics completed its initial $100 million share repurchase program, buying back 3.5 million shares at an average price of about $28.50. The Board has now authorized another $100 million program, providing flexibility for further share repurchases.
The earnings call summary highlights strong financial performance with significant growth in revenue and net income. The company's strategic initiatives, like the development of subcutaneous BRIUMVI and market expansion efforts, are promising. The Q&A section reveals optimism about future growth, despite some uncertainties in competitive dynamics and lack of specific guidance for 2026. The raised revenue guidance and strong market share growth for BRIUMVI further support a positive outlook. Overall, these factors suggest a likely positive stock price movement in the short term.
The earnings call reveals strong financial performance with increased revenue, exceeding expectations, and robust growth in BRIUMVI sales. The company raised its full-year revenue guidance, indicating confidence in future performance. Despite increased OpEx, profitability remains strong. The Q&A section highlights positive growth trends and strategic development plans, though some concerns about competition and market dynamics persist. Overall, the positive financial metrics, raised guidance, and strategic initiatives suggest a likely positive stock price reaction in the short term.
The earnings call reveals strong financial performance with revenue exceeding expectations, positive guidance, and a new partnership. Despite competitive pressures, no significant negative impact was reported. The Q&A section highlights market share gains and no adverse effects from competitors. The increased revenue guidance and strong earnings, coupled with promising product development, suggest a positive stock price movement over the next two weeks.
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