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Dec 31, 2021
TG Therapeutics Q4 2021 Earnings Report
TG Therapeutics reported fourth quarter and year-end 2021 financial results and provided a business update for 2022.
Key Takeaways
TG Therapeutics reported product revenue of $2.3 million for the fourth quarter of 2021. The company's R&D expenses were $62.6 million and SG&A expenses were $32.4 million. Net loss for the quarter was $93.3 million. The company ended the year with over $350 million in cash, cash equivalents and investment securities.
U.S. FDA accepted the BLA for ublituximab, with a PDUFA goal date of September 28, 2022.
FDA accepted a BLA for ublituximab and a supplemental New Drug Application (sNDA) for UKONIQ, applications were based on results from the UNITY-CLL Phase 3 trial.
Generated $6.5 million in total net UKONIQ revenue from launch through the end of Q4 2021.
Ended the year with more than $350 million in cash, cash equivalents and investment securities.
TG Therapeutics
TG Therapeutics
Forward Guidance
TG Therapeutics is focused on obtaining a favorable outcome at the upcoming ODAC meeting, obtaining FDA approval of U2 in CLL and SLL, obtaining FDA approval of ublituximab in RMS, and continuing to advance our early pipeline candidates.
Positive Outlook
- Obtain a favorable outcome at the upcoming ODAC meeting.
- Obtain FDA approval of U2 in CLL and SLL.
- Obtain FDA approval of ublituximab in RMS.
- Continue to advance our early pipeline candidates including TG-1501 (cosibelimab), our PDL1 inhibitor.
- Continue to advance TG-1701, our BTK inhibitor and TG-1801 our CD47/CD19 bispecific antibody.