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Sep 30, 2022
TG Therapeutics Q3 2022 Earnings Report
TG Therapeutics reported a net loss for Q3 2022, with a focus on preparing for the potential launch of ublituximab.
Key Takeaways
TG Therapeutics reported a net loss of $35.8 million for the third quarter ended September 30, 2022. The company focused on preparations for the potential launch of ublituximab for relapsing forms of multiple sclerosis (RMS).
FDA accepted the BLA for ublituximab to treat patients with RMS, with a PDUFA goal date of December 28, 2022.
New exploratory analyses from the ULTIMATE I and II Phase 3 trials were presented at ECTRIMS, showing a statistically significant reduction in annualized relapse rate (ARR) over 96 weeks compared to teriflunomide.
Net loss for the quarter was $35.8 million, a decrease compared to $85.6 million for the same period in 2021, primarily due to cost-saving measures and the withdrawal of UKONIQ.
Cash, cash equivalents, and investment securities totaled $197.7 million as of September 30, 2022, expected to fund operations into 2024.
Forward Guidance
TG Therapeutics expects SG&A expenses to increase as they prepare for the potential launch of ublituximab in RMS and believes its current resources will fund planned operations into 2024.
Positive Outlook
- Potential FDA approval of ublituximab for RMS by December 28, 2022.
- Strengthened commercial infrastructure to support the potential launch of ublituximab.
- Cost-saving measures implemented and withdrawal of UKONIQ from the market.
- Sufficient capital resources to fund planned operations into 2024.
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