TG Therapeutics, Inc. (NASDAQ:TGTX): Briumvi Drives Impressive Q1 2024 Results, Raising Full-Year Guidance

Published on September 24, 2024 | Ticker: TGTX

TG Therapeutics, Inc. (NASDAQ:TGTX) delivered an outstanding first quarter of 2024, driven by the continued strong commercial performance of its multiple sclerosis (MS) drug, Briumvi. TG Therapeutics reported total revenue of $63.5 million, including $50.5 million in net product revenue from Briumvi sales in the U.S. This robust performance exceeded TG Therapeutics' initial guidance and prompted an upward revision to its full-year revenue outlook.

Business Overview

Briumvi, TG Therapeutics' FDA-approved anti-CD20 monoclonal antibody for the treatment of relapsing forms of multiple sclerosis (RMS), has continued to gain traction in the market since its launch in January 2023. In the first quarter of 2024, TG Therapeutics reported a 25% quarter-over-quarter increase in Briumvi net sales, demonstrating the drug's growing demand and adoption among healthcare providers and patients.

The strong commercial performance was driven by several factors, including TG Therapeutics' targeted educational initiatives, effective sales force deployment, and comprehensive patient support programs. TG Therapeutics has successfully penetrated new accounts and prescribers, with approximately 160 new prescribers added in the first quarter, the majority of which were from academic centers. TG Therapeutics also continued to convert new infusion centers, adding 65 new accounts during the quarter.

Importantly, TG Therapeutics is seeing a diverse mix of patient types adopting Briumvi, including those who are treatment-naive and those who have switched from both non-CD20 and CD20 agents. This broad appeal underscores the drug's compelling clinical profile, which includes the ability to be administered as a one-hour infusion every six months following the starting dose.

Revised Guidance

Building on this momentum, TG Therapeutics is raising its full-year 2024 Briumvi net revenue guidance to $270 million to $290 million, up from the previous range of $220 million to $260 million. This revised guidance reflects the continued strong demand trends TG Therapeutics is observing and its confidence in Briumvi's trajectory.

Recent Developments

Beyond the impressive commercial performance, TG Therapeutics is also making progress on several strategic initiatives to further enhance Briumvi's value proposition. This includes efforts to improve the convenience of Briumvi's dosing regimen, develop a subcutaneous formulation, and explore the drug's potential in other autoimmune indications.

TG Therapeutics recently presented data from the ENHANCE trial, which evaluated the safety and efficacy of eliminating the four-hour starting dose for patients switching from a prior anti-CD20 therapy. The results suggest that Briumvi was well-tolerated when patients skipped the starting dose and went straight to the first full 450-milligram dose given as a one-hour infusion. These findings could further enhance Briumvi's convenience and patient experience.

Additionally, TG Therapeutics is preparing to enter human bioequivalence studies for a subcutaneous formulation of Briumvi this year. TG Therapeutics believes the subcutaneous CD20 market represents a significant opportunity, and it is working to develop a patient-friendly, convenient product to compete in this space.

Beyond Briumvi, TG Therapeutics has also expanded its pipeline through a recent partnership with Precision BioSciences. TG Therapeutics has acquired a worldwide license to Precision's azer-cel, an allogeneic CD19 CAR T cell therapy for autoimmune diseases and other non-oncology indications. TG Therapeutics plans to initiate a clinical trial evaluating azer-cel in autoimmune diseases later this year, further diversifying its portfolio and long-term growth prospects.

Financials

TG Therapeutics reported a net loss of $10.7 million, or $0.07 per share, in the first quarter of 2024, a significant improvement from the $39.2 million, or $0.28 per share, net loss in the same period of the prior year. TG Therapeutics' operating expenses during the quarter were well-controlled at $58 million, despite one-time charges related to the Precision BioSciences agreement.

Liquidity

As of March 31, 2024, TG Therapeutics had $209.8 million in cash, cash equivalents, and investment securities, providing TG Therapeutics with sufficient capital to fund its operations and continue investing in the growth of Briumvi and its pipeline.

Outlook

Looking ahead, TG Therapeutics is well-positioned to capitalize on Briumvi's momentum and further expand its commercial footprint. TG Therapeutics' focus on enhancing the drug's convenience, exploring new indications, and diversifying its pipeline with promising assets like azer-cel underscores its commitment to driving long-term value for shareholders.

Conclusion

Overall, TG Therapeutics' first-quarter 2024 results demonstrate TG Therapeutics' ability to execute on its strategic priorities and deliver strong financial performance. With Briumvi's continued success, a robust pipeline, and a solid financial position, TG Therapeutics appears poised to maintain its positive trajectory and solidify its position as a leading player in the MS and autoimmune disease treatment landscape.

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