8-K: TG Therapeutics Reports Strong Briumvi Launch, Exceeds Expectations in 2023

TG Therapeutics announced its fourth quarter and full year 2023 financial results, highlighting the successful launch of Briumvi and providing a positive outlook for 2024.

Summary

• TG Therapeutics reported fourth quarter and full year 2023 financial results, showcasing the successful commercial launch of BRIUMVI.
• BRIUMVI U.S. net revenue reached approximately $40 million in the fourth quarter and $89 million for the full year 2023, exceeding initial expectations.
• The company has set a BRIUMVI U.S. net revenue target of $220 to $260 million for 2024.
• TG Therapeutics also reported a net income of $12.7 million for the full year 2023, a significant improvement compared to a net loss of $198.3 million in 2022.
• The company's cash position at the end of 2023 was $217.5 million.
• The company anticipates that its cash, combined with projected BRIUMVI revenues, will be sufficient to fund operations into cash flow positivity.
• The company is planning to commence clinical development of subcutaneous BRIUMVI and trials for other autoimmune diseases.
• TG Therapeutics also entered into a global license agreement for azer-cel, an allogeneic CAR T therapy, for autoimmune disorders.

Sentiment

Score: 8

Explanation: The document presents a positive outlook with strong initial sales of BRIUMVI, a significant improvement in net income, and expansion into new therapeutic areas. However, there are some risks and challenges associated with commercialization and clinical development.

Positives

• The BRIUMVI launch has exceeded expectations, with strong initial sales and prescription numbers.
• The company has secured European approvals and a commercialization partnership, expanding BRIUMVI's market reach.
• TG Therapeutics has a strong cash position and anticipates achieving cash flow positivity.
• The company is expanding its pipeline with the addition of azer-cel for autoimmune diseases.
• The company has achieved a net income of $12.7 million for the full year 2023, a significant turnaround from the previous year's loss.
• The company has extended patent protection for BRIUMVI through 2042.

Negatives

• The company experienced a net loss of $14.4 million for the three months ended December 31, 2023.
• SG&A expenses increased due to commercialization efforts for BRIUMVI.
• There were 3 infection-related deaths in BRIUMVI-treated patients in clinical trials.
• Infusion reactions were common in BRIUMVI-treated patients, with 48% experiencing them in clinical trials.

Risks

• The company's ability to maintain and continue to maintain a commercial infrastructure for BRIUMVI is a risk.
• There is a risk that early trends in prescriptions are not maintained or that prescriptions are not filled.
• The company faces the risk of not obtaining and maintaining payor coverage.
• There is a risk that early HCP interest in BRIUMVI will not be sustained.
• The company faces the risk that momentum in sales for BRIUMVI will not build during the course of the year.
• The company faces the risk that the BRIUMVI launch does not continue to exceed expectations.
• The company faces the risk that BRIUMVI revenue targets will not be achieved.
• The company faces the risk of failing to obtain and maintain requisite regulatory approvals.
• The company faces the risk of failing to satisfy post-approval regulatory requirements.
• The company faces the risk of variation from the company's projections and estimates about the potential market for BRIUMVI.
• The company faces the risk of potential regulatory challenges to the company's plans to seek marketing approval for the product in jurisdictions outside of the U.S.
• The company faces the risk of uncertainties inherent in research and development.
• The company faces the risk that any individual patient's clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials.
• The company faces the risk of not achieving its 2024 development pipeline anticipated milestones in the timeframe projected or at all.
• The company faces the risk of general political, economic and business conditions.

Future Outlook

TG Therapeutics anticipates that its cash, combined with projected BRIUMVI revenues, will be sufficient to fund operations into cash flow positivity. The company also plans to commence clinical development of subcutaneous BRIUMVI and trials for other autoimmune diseases, as well as advance azer-cel into clinical development.

Management Comments

• Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, 2023 was an exciting year of execution for TG, which we believe has set the stage for a successful 2024.
• Mr. Weiss continued, The BRIUMVI launch exceeded our expectations, and we ended the year with approximately $89 million in U.S. net revenue and provided a BRIUMVI U.S. net revenue target of $220 $260 million for 2024.

Industry Context

The announcement highlights the growing market for multiple sclerosis treatments and the increasing focus on B-cell therapies. The successful launch of BRIUMVI positions TG Therapeutics as a key player in this space, competing with established treatments and other emerging therapies. The expansion into autoimmune diseases with azer-cel also reflects a broader trend in the industry to explore new applications for CAR T technology.

Comparison to Industry Standards

• The BRIUMVI launch is being compared to other MS treatments such as Ocrevus (ocrelizumab) from Roche and Kesimpta (ofatumumab) from Novartis, both of which are also anti-CD20 therapies.
• The $89 million in first year sales is a strong start, but still significantly lower than the peak sales of Ocrevus which is a multi-billion dollar drug.
• The company's target of $220-$260 million in 2024 is ambitious and will be closely watched by investors.
• The expansion into subcutaneous administration is a key differentiator as it offers a more convenient option for patients compared to intravenous infusions.
• The development of azer-cel for autoimmune diseases is a novel approach and could position TG Therapeutics as a leader in this emerging field, however it is still early in development compared to other CAR-T therapies in oncology.

Stakeholder Impact

• Shareholders will likely view the results positively due to the strong BRIUMVI launch and improved financial performance.
• Employees may benefit from the company's growth and expansion.
• Patients with MS will have access to a new treatment option with BRIUMVI.
• The company's suppliers and partners will benefit from the increased demand for BRIUMVI.

Next Steps

• Commence clinical development of subcutaneous BRIUMVI.
• Commence a trial evaluating BRIUMVI in an additional autoimmune disease 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.

Key Dates

Keywords

BRIUMVI, ublituximab, multiple sclerosis, RMS, autoimmune disease, CAR T therapy, azer-cel, commercialization, biopharmaceutical, net revenue