Release Date: May 01, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- TG Therapeutics Inc (TGTX, Financial) reported strong first-quarter financial results with total revenues exceeding $63 million, driven by robust sales of BRIUMVI in the U.S. which amounted to over $50 million.
- The company successfully secured a VA contract for BRIUMVI, enhancing its market presence and providing a significant opportunity to serve veterans while generating incremental revenue.
- TG Therapeutics Inc (TGTX) has expanded its commercial team and increased investment in patient awareness activities, contributing to the strong sales performance of BRIUMVI.
- The company announced the issuance of three new patents, extending the patent protection for BRIUMVI through 2042, which supports long-term commercial prospects.
- TG Therapeutics Inc (TGTX) is actively pursuing expansion opportunities for BRIUMVI in other autoimmune diseases, with plans to launch clinical trials later this year, potentially broadening the drug's market.
Negative Points
- Despite strong revenue growth, TG Therapeutics Inc (TGTX) reported a net loss of approximately $10.7 million for the first quarter of 2024, indicating ongoing financial challenges.
- The company faces significant competition in the MS treatment market, particularly from other established CD20 monoclonal antibodies, which could impact market share and profitability.
- TG Therapeutics Inc (TGTX) is heavily reliant on the success of BRIUMVI, with a substantial portion of its revenue tied to this single product, posing risks if the drug faces setbacks in clinical trials or market acceptance.
- The company's operating expenses remain high, with first-quarter expenses totaling approximately $58 million, which could strain financial resources if revenue growth does not continue at the expected rate.
- TG Therapeutics Inc (TGTX) is still in the early stages of exploring the subcutaneous formulation of BRIUMVI, and any delays or negative outcomes in the development process could hinder future revenue prospects.
Q & A Highlights
Q: Regarding sales in the EU, when could we expect Neuraxpharm to begin offering details?
A: Michael Weiss, CEO of TG Therapeutics, indicated that it's unlikely Neuraxpharm will provide public guidance or information as they are a private company.
Q: How much of BRIUMVI's fiscal year '24 guidance raise was due to the recently announced VA contract?
A: Adam Waldman, Chief Commercial Officer, clarified that the VA contract was not factored into the guidance raise due to its gradual implementation starting in June.
Q: In the most recent cut of the enhanced data presented at ACTRIMS, three patients in cohort two had their infusion slowed down or interrupted. Could you provide any details on these patients?
A: Michael Weiss explained that there was nothing particular about these patients and the infusions were only modestly slowed, close to the one-hour mark, indicating overall good tolerance.
Q: Thinking about the potential opportunity in the so-called crap gap with Ocrevus, is this something that you think you'll be able to produce data on or somehow address this with your sales force?
A: Michael Weiss mentioned that they will try to capture data through the ENHANCE study to provide at least some anecdotal information about patient-reported experiences regarding the crap gap.
Q: How would you characterize the repeat infusion rate you have been seeing?
A: Adam Waldman reported that the 24-week persistence is in line or slightly better than their expectations of about 85%, indicating good patient retention on BRIUMVI.
Q: What's your base case assumption on where the dosing frequency could land for subcutaneous BRIUMVI?
A: Michael Weiss expressed confidence in achieving a dosing frequency that balances convenience and efficacy, suggesting that even if it ended up being once a month, they would likely proceed with development.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
