Market Dynamics and Financial Trajectory for the Biologic Drug: BRIUMVI
Introduction
BRIUMVI (ublituximab-xiiy), developed by TG Therapeutics, has been making significant waves in the pharmaceutical industry, particularly in the treatment of relapsing forms of multiple sclerosis (MS). Since its launch in January 2023, the drug has demonstrated robust growth and strong market acceptance. Here, we delve into the market dynamics and financial trajectory of BRIUMVI.
Launch and Initial Performance
TG Therapeutics launched BRIUMVI in January 2023, and the drug quickly gained traction. In its first partial year, BRIUMVI generated approximately $90 million in U.S. net revenue, exceeding initial expectations[4].
Revenue Growth
The revenue growth of BRIUMVI has been nothing short of remarkable. Here are some key milestones:
- Second Quarter 2024: U.S. BRIUMVI net revenue reached $72.6 million, representing over 350% growth compared to the same quarter in 2023[1].
- Third Quarter 2024: The U.S. net revenue for BRIUMVI was $83.3 million, marking a 15% increase from the previous quarter and a 230% year-over-year growth[2][3].
- Full-Year 2024 Guidance: Based on the strong performance, TG Therapeutics has raised its full-year 2024 revenue guidance for BRIUMVI to between $300 million and $305 million, up from the initial forecast of $220 million to $260 million[2][3].
Market Penetration
BRIUMVI has achieved significant market penetration since its launch:
- Prescriptions and Providers: As of the second quarter of 2024, the company had received approximately 5,850 new patient prescriptions from about 950 healthcare providers at over 525 treatment centers[1].
- Expansion: By the third quarter of 2024, the number of prescribers had increased to nearly 1,100, and the treatment centers to around 600[2].
Commercialization Efforts
TG Therapeutics has been aggressive in its commercialization efforts:
- National Contract with VA: BRIUMVI was awarded a national contract with the Department of Veterans Affairs (VA) to be the preferred anti-CD20 agent for patients with relapsing forms of MS[1].
- Coverage and Access: The company has achieved coverage for 95% of commercial and Medicare lives within nine months of launch, indicating strong market access[4].
Clinical Developments
In addition to its commercial success, TG Therapeutics is also advancing the clinical profile of BRIUMVI:
- Subcutaneous Formulation: The company is developing a subcutaneous version of BRIUMVI, which could represent a significant new market opportunity. Preliminary subcutaneous formulation studies are underway, with plans to enter human bioequivalent studies[4].
- Infusion Time Reduction: Efforts are being made to shorten infusion times and minimize infusion visits, enhancing the patient treatment experience[3].
- Long-Term Follow-Up: Data from the ULTIMATE I & II and ENHANCE trials showed that 92% of patients were free from disability progression after five years, highlighting the drug's long-term efficacy[2].
Financial Position
TG Therapeutics' financial position has been bolstered by the success of BRIUMVI:
- Cash Reserves: As of the third quarter of 2024, the company had approximately $341 million in cash, cash equivalents, and investment securities, providing a strong financial cushion for ongoing operations and R&D activities[2].
- Operating Expenses: The company's operating expenses for the third quarter were approximately $50 million, with full-year expenses expected to be well below the guided range of $250 million[2].
Expansion into Other Autoimmune Diseases
TG Therapeutics is not limiting BRIUMVI's potential to just MS. The company is exploring its use in other autoimmune diseases:
- New Indications: Plans are underway to launch the first autoimmune trial outside of MS in 2024, aiming to broaden the drug's therapeutic scope[4].
- CD19 CAR T Cell Therapy: The company has also licensed a CD19 CAR T cell therapy program, which could be a meaningful treatment for various autoimmune disorders[5].
Market Share and Competitive Landscape
BRIUMVI is positioned to become a leading CD20 therapy in the MS market:
- Market Share Goals: The company aims to achieve the number one prescribed anti-CD20 in terms of dynamic market share[3].
- Competitive Advantage: With its strong commercial infrastructure and positive feedback from healthcare providers and patients, BRIUMVI is well-placed to capture a significant share of the CD20 market, expected to account for 50% to 55% of new MS patients annually[4].
Key Takeaways
- Robust Revenue Growth: BRIUMVI has shown extraordinary revenue growth, with a 1341.56% increase over the last twelve months as of Q2 2024.
- Strong Market Penetration: The drug has been prescribed by nearly 1,100 healthcare providers across over 600 treatment centers.
- Clinical Advancements: Efforts to develop a subcutaneous version and reduce infusion times are underway, enhancing patient treatment experiences.
- Financial Stability: TG Therapeutics has a strong cash position and managed operating expenses, supporting continued R&D and commercial activities.
- Expansion Plans: The company is exploring BRIUMVI's use in other autoimmune diseases and developing new therapies like CD19 CAR T cell therapy.
FAQs
What is BRIUMVI used for?
BRIUMVI (ublituximab-xiiy) is used for the treatment of relapsing forms of multiple sclerosis (MS).
How has BRIUMVI performed financially since its launch?
Since its launch in January 2023, BRIUMVI has shown robust financial performance, with U.S. net revenue reaching $90 million in the first partial year. In the third quarter of 2024, it achieved $83.3 million in U.S. net revenue, with full-year guidance raised to $300-$305 million.
What are the key clinical developments for BRIUMVI?
Key clinical developments include the development of a subcutaneous formulation, efforts to reduce infusion times, and long-term follow-up data showing 92% of patients free from disability progression after five years.
How is TG Therapeutics expanding BRIUMVI's market reach?
The company is expanding BRIUMVI's market reach by securing national contracts, such as with the VA, achieving broad coverage for commercial and Medicare lives, and exploring new indications in other autoimmune diseases.
What is the financial position of TG Therapeutics?
As of the third quarter of 2024, TG Therapeutics had approximately $341 million in cash, cash equivalents, and investment securities, and managed operating expenses are expected to be below the guided range.
Sources
- TG Therapeutics Reports Second Quarter 2024 Financial Results and Raises BRIUMVI Ublituximab-xiiy Full Year Revenue Guidance. Biospace.
- Earnings call: TG Therapeutics reports robust growth for BRIUMVI. Investing.com.
- TG Therapeutics Reports Third Quarter 2024 Financial Results and Raises BRIUMVI Ublituximab-xiiy Full Year Revenue Guidance. Biospace.
- Earnings call: TG Therapeutics reports robust BRIUMVI sales in 2023. Investing.com.
- TG Therapeutics Provides Preliminary Fourth Quarter and Full Year Updates. Stocktitan.
