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01/10 16:54
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
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.
U.S. net sales for BRIUMVI $139 million in Q2 2025, representing robust growth and exceeding internal expectations. This growth was driven by increased new prescribers, new accounts, and the highest volume of new patient enrollments to date.
Total revenue $141.1 million for Q2 2025, including U.S. net product revenue of $138.8 million. This represents a 91% increase compared to the same period last year and a 16% growth over Q1 2025. The increase was attributed to the continued uptake and demand for BRIUMVI.
Operating expenses (OpEx) $71 million for Q2 2025, up from $46.9 million in Q2 2024 but down $10 million from Q1 2025. The year-over-year increase was due to investments in R&D for subcutaneous BRIUMVI and commercial efforts, while the sequential decline was due to timing of development activities.
GAAP net income $28.2 million or $0.17 per diluted share for Q2 2025, compared to $6.9 million or $0.04 per diluted share in Q2 2024. The increase reflects strong revenue growth and operational performance.
Cash, cash equivalents, and investment securities $279 million as of the end of Q2 2025, remaining flat from Q1 2025. This stability supports the company's long-term strategy and future investments.
BRIUMVI adoption: Approximately 1 in every 3 new IV anti-CD20 patients are prescribed BRIUMVI, showing significant progress in market share.
Subcutaneous BRIUMVI development: Development of subcu BRIUMVI in the ENHANCE study aims to expand the addressable market by 35%-40% by offering a self-administered option. Phase III trial enrollment to begin soon, with a BLA filing expected in 2027 and launch in 2028.
Pipeline expansion: First patient dosed with azer-cel, an investigational allogeneic CD19-directed CAR-T therapy, and exploration of BRIUMVI for myasthenia gravis.
Market share growth: BRIUMVI is steadily increasing its share within the $8 billion annual U.S. MS CD20 market, with significant headroom for growth.
National TV campaign: Launched first-ever national TV campaign, leading to increased patient awareness and website traffic.
Revenue growth: Q2 2025 U.S. net sales for BRIUMVI totaled $139 million, a 91% increase YoY and 16% growth QoQ. Full-year revenue guidance raised to $575 million.
Operational expenses: Total OpEx for Q2 2025 was $71 million, driven by R&D investments in subcutaneous BRIUMVI and commercial efforts.
Strategic positioning: TG aims to be the only company offering both IV and self-administered anti-CD20 options, simplifying treatment decisions and enhancing market leadership.
Regulatory Risks: The company acknowledges that forward-looking statements are subject to risks that may cause actual results to differ materially, as outlined in their SEC filings. This includes potential regulatory hurdles for new product approvals, such as the subcutaneous formulation of BRIUMVI and updates to IV BRIUMVI dosing schedules.
Market Competition: The company faces competitive pressures in the anti-CD20 therapy market for relapsing MS, which generates over $8 billion annually in the U.S. While BRIUMVI is gaining market share, competition from existing and potentially new therapies remains a challenge.
Pipeline Development Risks: The development of subcutaneous BRIUMVI and other pipeline projects like the CD19 CAR-T therapy and BRIUMVI for myasthenia gravis involve clinical and operational risks, including the potential for delays in pivotal trials and regulatory approvals.
Economic and Operational Costs: The company reported increased operating expenses, particularly in R&D and SG&A, driven by investments in the subcutaneous formulation of BRIUMVI and commercial efforts. This could impact profitability if revenue growth does not meet expectations.
Patient and Provider Adoption: While BRIUMVI adoption is growing, the company is reliant on continued patient and provider acceptance, which could be influenced by market dynamics, awareness campaigns, and the availability of alternative therapies.
Development of subcutaneous (subcu) BRIUMVI: TG Therapeutics is advancing the development of subcu BRIUMVI, aiming to expand its market share by addressing the 35%-40% of the anti-CD20 market that prefers self-administered options. A pivotal Phase III trial will begin patient enrollment in the coming weeks, with completion expected in 2026, a BLA filing in 2027, and potential launch in 2028.
Enhancements to IV BRIUMVI: A Phase III trial is underway to evaluate a simplified dosing schedule for IV BRIUMVI, potentially consolidating the day 1 and day 15 infusions into a single 600-milligram infusion. Results are expected in 2026, with a goal of an updated label in 2027.
Expansion of BRIUMVI's indications: TG Therapeutics is exploring the use of BRIUMVI in treating myasthenia gravis and has initiated trials for progressive MS using azer-cel, an investigational allogeneic CD19-directed CAR-T therapy.
Revenue guidance for BRIUMVI: The company has raised its full-year U.S. BRIUMVI net revenue guidance to $575 million for 2025, reflecting strong growth trends and increasing market penetration.
Market share growth for BRIUMVI: BRIUMVI is estimated to account for nearly one-third of new IV anti-CD20 prescriptions, with significant growth potential in the $8 billion U.S. MS market.
Media and marketing investments: A national television campaign and multichannel strategy are expected to drive patient awareness and brand recognition, contributing to BRIUMVI's growth trajectory.
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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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