TGTX - TG Therapeutics Provides Preliminary Fourth Quarter and Full Year 2023 Net Revenue and 2024 Anticipated Milestones | Benzinga
Preliminary U.S. BRIUMVI fourth quarter and full year 2023 net product revenue of approximately $40 million and $89 million, respectively
Preliminary year-end 2023 cash position of approximately $215 million
NEW YORK, Jan. 10, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) yesterday announced preliminary U.S. net product revenue for BRIUMVI® for the fourth quarter and full year ended December 31, 2023 (unaudited), as well as financial guidance and development milestones for 2024, during a preannounced presentation at the 42nd Annual J.P Morgan Healthcare Conference. An audio replay of the event, as well as the corresponding slide deck are available on the Investors and Media section of the TG corporate website at ir.tgtherapeutics.com/events.
Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, "We are excited to share our preliminary fourth quarter and year end U.S. BRIUMVI net product revenue. As we head into 2024, we have our sights set on achieving revenue and expense targets and have built an ambitious plan to potentially expand the utility of BRIUMVI into new indications and for use as a subcutaneous injection. We are also excited to expand our R&D program with the recent licensing of azer-cel, an allogeneic CD19 CAR T therapy which we believe has the potential to become a meaningful therapy to treat various autoimmune disorders."
Preliminary Fourth Quarter and Full Year 2023 Updates (based on unaudited financial information)
- BRIUMVI U.S. net product revenue expected to be approximately $40 million and $89 million for the fourth quarter and full year of 2023, respectively
- Year-end 2023 cash position of approximately $215 million
Preliminary selected financial information presented in this release are unaudited, subject to financial closing procedures and adjustment, and provided as an approximation in advance of the Company's announcement of complete financial results planned to occur February 2024.
2024 Target Guidance
- BRIUMVI U.S. net product revenue targets of approximately $41-$46 million and $220-$260 million for the first quarter and full year 2024, respectively
- Full year 2024 target operating expense of approximately $250 million
2024 Development Pipeline Anticipated Milestones
- Commence clinical development of subcutaneous BRIUMVI
- Commence a trial evaluating BRIUMVI in additional autoimmune diseases outside of Multiple Sclerosis (MS)
- Commence a trial evaluating azer-cel in autoimmune disease
- Present data from the ENHANCE Phase 3b CD20 switch trial at multiple conferences throughout the year
ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as relapsing forms of multiple sclerosis (RMS). BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.
BRIUMVI is indicated for the treatment of adults with RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
A list of authorized specialty distributors can be found at www.briumvi.com.
IMPORTANT SAFETY INFORMATION
Contraindications: BRIUMVI is contraindicated in patients with:
- Active Hepatitis B Virus infection
- A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS
Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.
Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.
Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection ...