Introduction to Ublituximab-xiiy (BRIUMVI)
Ublituximab-xiiy, marketed as BRIUMVI, is a biologic drug developed by TG Therapeutics for the treatment of relapsing forms of multiple sclerosis (RMS). This anti-CD20 monoclonal antibody has shown significant promise in the market, driving substantial growth and financial performance for TG Therapeutics.
Commercialization and Market Uptake
U.S. Commercialization
BRIUMVI has experienced a robust commercial launch in the United States. In the third quarter of 2024, the drug generated $83.3 million in U.S. net revenue, marking a continuation of its strong commercial momentum[2][5].
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Revenue Growth: The third quarter revenue represents a significant increase from the second quarter of 2024, where U.S. BRIUMVI net revenue was $72.6 million. This growth is part of a larger trend, with year-over-year revenue growth exceeding 350% in the second quarter of 2024[3][4].
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Prescription Volume: Since its launch, BRIUMVI has received approximately 5,850 new patient prescriptions from about 950 healthcare providers across 525 centers. This includes over 1,400 prescriptions in the second quarter of 2024 alone[3][4].
European Commercialization
In addition to its U.S. success, BRIUMVI has also made strides in the European market. A $12.5 million milestone payment was received under the Neuraxpharm Commercialization Agreement for the first key market commercial launch of BRIUMVI in the European Union, which occurred in the first quarter of 2024[2][5].
Financial Performance
Revenue Guidance
TG Therapeutics has consistently raised its full-year revenue guidance for BRIUMVI. As of the third quarter 2024, the company has raised its full-year 2024 U.S. BRIUMVI net revenue target to $300 - $305 million, reflecting the drug's strong market performance[2][5].
Net Income and Cash Position
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Net Income: For the three and nine months ended September 30, 2024, TG Therapeutics reported net income of $3.9 million and $0.1 million, respectively. While these figures are lower than the previous year, they are influenced by various factors including increased R&D and SG&A expenses[2][5].
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Cash Position: As of September 30, 2024, TG Therapeutics had $341.0 million in cash, cash equivalents, and investment securities. This financial position, combined with projected revenues from BRIUMVI, is expected to be sufficient to fund the company's business operations based on its current operating plan[2].
Research and Development (R&D) Expenses
R&D Activities
The company has seen an increase in R&D expenses, primarily due to several key initiatives:
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License and Milestone Expenses: Related to the license agreement with Precision BioSciences, Inc.[2][5].
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Manufacturing and Development Costs: Associated with the development of a subcutaneous version of ublituximab[2][5].
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Clinical Trials: TG Therapeutics has initiated a Phase 1 study for subcutaneous ublituximab in RMS patients and received FDA IND clearance for azer-cel, an allogeneic CD19 CAR-T, for patients with progressive MS[3][4].
Selling, General, and Administrative (SG&A) Expenses
SG&A Costs
The increase in SG&A expenses is attributed to various costs associated with the commercialization of BRIUMVI, including personnel, consultants, and other selling and administrative costs. For the three and nine months ended September 30, 2024, SG&A expenses were approximately $42.0 million and $115.3 million, respectively[2].
Strategic Initiatives and Partnerships
Credit Facility and Share Repurchase Program
TG Therapeutics established a $250 million credit facility with HealthCare Royalty and Blue Owl Capital. This facility is used to repay existing debt and initiate a share repurchase program, allowing the company to manage its financial obligations while preserving cash for commercial infrastructure, marketing, and R&D investments[3][4].
Contract with the Department of Veterans Affairs
BRIUMVI was awarded a national contract with the Department of Veterans Affairs (VA) to be the preferred anti-CD20 agent listed on the VA National Formulary for patients with RMS. This contract further solidifies BRIUMVI's market position and accessibility[3][4].
Market Position and Future Outlook
Market Share and Growth
TG Therapeutics aims to make BRIUMVI the number one prescribed anti-CD20 agent in terms of dynamic market share. The strong commercial launch and continuous growth in revenue and prescriptions indicate that the company is on track to achieve this goal[1].
Patient-Centric Initiatives
The company is focused on improving the treatment experience for individuals living with RMS. Initiatives include shortening infusion times, minimizing infusion visits, and developing a subcutaneous BRIUMVI option, which aligns with patient needs and enhances market competitiveness[1].
Key Takeaways
- Strong Revenue Growth: BRIUMVI has shown significant revenue growth, with U.S. net revenue of $83.3 million in the third quarter of 2024 and a raised full-year revenue target of $300 - $305 million.
- Robust Market Uptake: The drug has received over 5,850 new patient prescriptions since its launch, indicating strong market acceptance.
- Increased R&D and SG&A Expenses: These expenses are driven by ongoing clinical trials, manufacturing development, and commercialization efforts.
- Strategic Financial Management: The establishment of a $250 million credit facility and a share repurchase program helps manage debt and preserve cash for future investments.
- Patient-Centric Initiatives: TG Therapeutics is committed to improving the treatment experience for RMS patients through various development initiatives.
FAQs
Q: What is the current revenue guidance for BRIUMVI in 2024?
A: The full-year 2024 U.S. BRIUMVI net revenue target has been raised to $300 - $305 million[2][5].
Q: How many new patient prescriptions has BRIUMVI received since its launch?
A: BRIUMVI has received approximately 5,850 new patient prescriptions since its launch[3][4].
Q: What are the key R&D initiatives for TG Therapeutics?
A: Key initiatives include a Phase 1 study for subcutaneous ublituximab and FDA IND clearance for azer-cel in progressive MS[3][4].
Q: What is the current cash position of TG Therapeutics?
A: As of September 30, 2024, TG Therapeutics had $341.0 million in cash, cash equivalents, and investment securities[2].
Q: What is the significance of the contract with the Department of Veterans Affairs for BRIUMVI?
A: BRIUMVI was awarded a national contract to be the preferred anti-CD20 agent listed on the VA National Formulary for patients with RMS, enhancing its market position and accessibility[3][4].
Sources
- TG Therapeutics Reports Third Quarter 2024 Financial Results and Raises BRIUMVI (ublituximab-xiiy) Full Year Revenue Guidance. Biospace.
- TG Therapeutics Reports Third Quarter 2024 Financial Results and Raises BRIUMVI (ublituximab-xiiy) Full Year Revenue Guidance. GlobeNewswire.
- TG Therapeutics Reports Second Quarter 2024 Financial Results and Raises BRIUMVI (ublituximab-xiiy) Full Year Revenue Guidance. StockTitan.
- TG Therapeutics Reports Second Quarter 2024 Financial Results and Raises BRIUMVI (ublituximab-xiiy) Full Year Revenue Guidance. Business Insider.
- TG Therapeutics Reports Third Quarter 2024 Financial Results and Raises BRIUMVI (ublituximab-xiiy) Full Year Revenue Guidance. TG Therapeutics Investor Relations.
Last updated: 2024-12-22
