TG Therapeutics' Briumvi Exceeds Expectations, Eyes Subcutaneous Formulation and Azer-Cel Trial in MS
核心洞察
TG Therapeutics announced that Briumvi's 2024 sales reached $310 million, surpassing initial expectations, driven by strong adoption in relapsing forms of multiple sclerosis (搜索) (RMS).
The company anticipates $540 million in total global revenue for 2025, with $525 million expected from Briumvi sales, signaling continued growth and market penetration.
A pivotal program for a subcutaneous formulation of Briumvi is slated to begin in 2025, offering a more convenient administration route for RMS patients.
TG Therapeutics (TGTX) has announced preliminary net product revenues for Briumvi (ublituximab-xiiy) for the fourth quarter and full year 2024, exceeding initial company expectations. The company also provided financial guidance for 2025 and outlined expected milestones related to Briumvi label expansion studies and other pipeline candidates. Shares of TG Therapeutics were up 7.5% following the announcement.
Briumvi, a novel monoclonal antibody targeting CD20 (搜索)-expressing B-cells, is approved for the treatment of relapsing forms of multiple sclerosis (搜索) (RMS). The drug's unique glycoengineering allows for efficient B-cell depletion at low doses.
Briumvi Sales Performance
Preliminary net product revenues from Briumvi sales were $103.6 million in the fourth quarter and $310 million for the full year 2024. This exceeded the company's guidance of $300-$305 million provided with the third-quarter 2024 earnings release. TG Therapeutics had approximately $310 million in cash at the end of 2024.
2025 Guidance and Pipeline Development
TG Therapeutics anticipates worldwide revenues of approximately $540 million in 2025, including net product revenues of approximately $525 million from Briumvi sales in the United States. The company expects operating expenses of around $300 million for 2025.
A key development is the planned pivotal program for a self-administered subcutaneous formulation of Briumvi for treating patients with RMS, expected to begin in 2025. This new formulation aims to offer a more convenient dosing frequency of at least every other month.
The FDA has cleared the investigational new drug application (IND) for TG Therapeutics’ pipeline candidate, azercabtagene zapreleucel (azer-cel), for the treatment of progressive forms of multiple sclerosis (搜索) (MS). Enrollment of participants in the phase I study on azer-cel in progressive MS is anticipated to begin in 2025.
Management Commentary
Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, “2024 was a great year for TG, and we are excited to share preliminary fourth quarter and year end U.S. BRIUMVI net product revenue which far exceeded our initial expectations. We believe BRIUMVI is well positioned to continue to grow and provide value to patients and physicians.”
Weiss added, “On the development front we were excited to provide an update on our subcutaneous BRIUMVI work, which should allow us to commence a pivotal program in 2025 evaluating a self-administered subcutaneous product with an expected dosing frequency of least every other month, a product profile we believe will be attractive to patients and healthcare providers. In 2025 we also plan to launch pivotal trials aimed at further optimizing intravenous BRUIMVI for patients with RMS, continuing to maintain what we believe is a best-in-class profile. We also look forward to evaluating BRIUMVI in other indications outside of MS, and enrolling patients with progressive MS into a Phase 1 trial of our allogeneic CD19-directed CAR-T, azer-cel.”
About Briumvi
Briumvi is a monoclonal antibody that targets a unique epitope on CD20 (搜索)-expressing B-cells. It is indicated for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Safety Information
Briumvi carries contraindications for patients with active Hepatitis B Virus infection (搜索) or a history of life-threatening infusion reaction to Briumvi. Warnings and precautions include the risk of infusion reactions, infections, Hepatitis B Virus reactivation, and Progressive Multifocal Leukoencephalopathy (搜索) (PML).