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Jun 30, 2021
TG Therapeutics Q2 2021 Earnings Report
TG Therapeutics reported financial results for the second quarter of 2021 and provided a business update.
Key Takeaways
TG Therapeutics reported a net product revenue of $1.5 million from UKONIQ sales in Q2 2021. The company's R&D expenses increased due to licensing milestone fees, while SG&A expenses rose due to the launch of UKONIQ and preparations for potential launches of U2 and ublituximab. The net loss for the quarter was $78.5 million, and the company's cash, cash equivalents, and investment securities totaled $456.2 million as of June 30, 2021.
Launched UKONIQ in the U.S. and generated $2.3M in total net revenue through Q2 2021.
Achieved broad U.S. payor coverage for UKONIQ, covering more than 90% of Medicare and commercial lives.
Received FDA acceptance of BLA/sNDA for U2 to treat CLL and SLL with a PDUFA goal date of March 25, 2022.
Submitted a BLA for ublituximab for the treatment of patients with RMS in Q3 2021.
TG Therapeutics
TG Therapeutics
Forward Guidance
TG Therapeutics plans to focus on commercializing UKONIQ, submit a BLA for ublituximab in RMS, obtain approval for U2 in CLL and SLL, enroll into the ULTRA-V Phase 3 trial, and advance early pipeline candidates.
Positive Outlook
- Focus on the commercialization of UKONIQ in R/R MZL and FL and expand commercialization capabilities in preparation for a potential launch of U2 in CLL and ublituximab in RMS
- Submit a BLA for ublituximab for the treatment of patients with RMS in Q3 2021, based on positive results from the ULTIMATE I and II Phase 3 trials
- Obtain approval for U2 in CLL and SLL by the PDUFA goal date of March 25, 2022
- Enroll into the newly launched ULTRA-V Phase 3 trial evaluating the triple combination of U2 plus venetoclax
- Continue to advance our early pipeline candidates including TG-1501 (cosibelimab), TG-1701 and TG-1801
Challenges Ahead
- Our ability to establish, maintain and enhance our commercial infrastructure, and to successfully market and sell UKONIQ or future products, if approved
- Our ability to meet post-approval regulatory requirements for UKONIQ and future products, including submission of sufficient data from a confirmatory clinical study, and post-approval compliance obligations
- The potential for variation from the Company’s projections and estimates about the potential market for UKONIQ or the Company’s product candidates due to a number of factors, including for example, limitations that regulators may impose on the required labeling for the product
- Actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials
- The accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing