TG Therapeutics Q2 2022 Earnings Report
Key Takeaways
TG Therapeutics reported its Q2 2022 financial results, showing a net loss of $40.5 million. The company's primary focus is on gaining FDA approval for ublituximab for RMS, with a PDUFA goal date of December 28, 2022. Cost-saving measures have been implemented, leading to a reduced cash burn.
FDA accepted the BLA for ublituximab for RMS with a PDUFA goal date of December 28, 2022.
Presented new exploratory analyses from the ULTIMATE I and II Phase 3 trials at CMSC and EAN, demonstrating a statistically significant reduction in ARR with ublituximab compared to teriflunomide.
Net loss for the quarter was $40.5 million, a decrease compared to $78.5 million in Q2 2021, due to cost-saving measures and the withdrawal of UKONIQ.
Cash, cash equivalents, and investment securities totaled $231.8 million as of June 30, 2022, expected to fund operations into the second half of 2023.
TG Therapeutics
TG Therapeutics
Forward Guidance
TG Therapeutics anticipates an increase in selling, general, and administrative expenses as it prepares for the potential launch of ublituximab in RMS. The company believes its current cash position will be sufficient to fund operations into the second half of 2023.
Positive Outlook
- Potential FDA approval of ublituximab by December 28, 2022.
- Ublituximab has the potential to be a meaningful treatment option for patients with relapsing forms of multiple sclerosis.
- Cost-saving measures have been implemented, resulting in a lower than expected 2Q burn.
- Company believes it is in a good financial position as it approaches the potential launch of ublituximab.
- Cash position expected to fund operations into the second half of 2023.
Challenges Ahead
- Forward-looking statements are subject to risks and uncertainties.
- Potential for variation from the Company’s projections and estimates about the potential market for ublituximab.
- Risk that regulatory authorities disagree with the conclusions reached or data disclosed.
- Reliance on third parties to perform manufacturing, distribution and supply services.
- Risk that the ongoing COVID-19 pandemic and associated government control measures have an adverse impact on clinical trials and other research and development plans.