8-K: TG Therapeutics Exceeds Expectations with Strong First Quarter Briumvi Sales, Raises Full-Year Guidance

TG Therapeutics reported strong first-quarter sales of Briumvi, exceeding expectations and leading to an increase in full-year revenue guidance.

Summary

• TG Therapeutics announced its first quarter 2024 financial results, highlighted by strong sales of BRIUMVI.
• BRIUMVI U.S. net revenue reached $50.5 million, representing over 25% quarter-over-quarter growth.
• Total revenue for the quarter was $63.5 million, including a $12.5 million milestone payment for the European launch of BRIUMVI.
• The company received over 1,250 new BRIUMVI prescriptions in Q1 2024, also showing over 25% quarter-over-quarter growth.
• TG Therapeutics has updated its full-year BRIUMVI U.S. net revenue guidance to $270 to $290 million, up from the previous guidance of $220 to $260 million.
• The company's net loss for the quarter was $10.7 million, a significant improvement from the $39.2 million loss in the same period last year.
• Research and development expenses increased to $32.7 million, primarily due to a license agreement and subcutaneous development work.
• Selling, general, and administrative expenses rose to $34.6 million due to the BRIUMVI commercial launch scale-up.
• The company's cash position was $209.8 million as of March 31, 2024, which they believe is sufficient to fund operations to cash flow positivity.

Sentiment

Score: 8

Explanation: The document conveys a strong positive sentiment due to the better-than-expected sales, increased revenue guidance, and progress in clinical development. The company's financial position is also improving, and the expansion into new markets and therapeutic areas is promising. However, there are some risks and expenses that temper the overall sentiment.

Positives

• BRIUMVI sales are strong, exceeding initial expectations and showing significant quarter-over-quarter growth.
• The company has successfully launched BRIUMVI in Europe, triggering a milestone payment.
• The increase in full-year revenue guidance indicates confidence in continued sales growth.
• The company is expanding its pipeline with the addition of azer-cel.
• The company is actively working on improving the convenience of BRIUMVI administration with a subcutaneous formulation.
• The company has secured a national contract with the Department of Veterans Affairs for BRIUMVI.
• The net loss has significantly decreased compared to the same period last year.

Negatives

• Research and development expenses have increased significantly due to the license agreement and development costs.
• Selling, general, and administrative expenses have also increased due to the commercial launch of BRIUMVI.
• The company is still operating at a net loss, although it has improved from the previous year.
• There were 3 infection-related deaths in BRIUMVI-treated patients in MS clinical trials.

Risks

• The company's ability to maintain and grow the commercial infrastructure for BRIUMVI is crucial.
• There is a risk that early prescription trends may not be sustained.
• Failure to obtain and maintain payor coverage could impact sales.
• The company relies on third parties for manufacturing and supply of BRIUMVI.
• There are potential regulatory challenges to seeking marketing approval in other jurisdictions.
• The company faces risks inherent in research and development.
• The company may not achieve its 2024 development pipeline milestones.
• There are risks associated with the safety profile of BRIUMVI, including infusion reactions and infections.

Future Outlook

The company anticipates that its current cash position, combined with projected BRIUMVI revenues, will be sufficient to fund operations to cash flow positivity. They have increased their full year revenue guidance for BRIUMVI to $270 to $290 million. They also plan to commence clinical development of subcutaneous BRIUMVI, commence a trial evaluating BRIUMVI in an additional autoimmune disease outside of MS, and commence a trial evaluating azer-cel in autoimmune disease.

Management Comments

• We were extremely pleased with the strong sales of just over $50 million in BRIUMVI U.S. net revenue for the first quarter of 2024, which was ahead of our guidance.
• We believe this strong momentum will continue to build throughout 2024 and are pleased to update our yearly guidance to $270 to $290 million in BRIUMVI U.S. net revenue in 2024.
• We are also pleased to be making strides towards our clinical goals for the year which include enhancing the convenient dosing of IV BRIUMVI, developing a subcutaneous form of BRIUMVI, moving BRIUMVI into additional indications beyond MS, and advancing our recent pipeline addition, azer-cel, an allogeneic CAR T, into clinical development.

Industry Context

The announcement reflects a positive trend in the multiple sclerosis treatment market, where new therapies like BRIUMVI are gaining traction. The expansion into Europe and the development of a subcutaneous formulation are strategic moves to increase market share and patient convenience. The addition of azer-cel also positions the company to address other autoimmune disorders.

Comparison to Industry Standards

• The reported Q1 2024 BRIUMVI revenue of $50.5 million is a strong performance compared to other recent launches of MS therapies. For example, Kesimpta (ofatumumab) from Novartis, a similar anti-CD20 monoclonal antibody, had a slower initial uptake.
• The quarter-over-quarter growth of >25% for BRIUMVI prescriptions and revenue indicates a successful launch trajectory, which is better than many other new drugs in the MS space.
• The updated full-year guidance of $270 to $290 million suggests a high level of confidence in the product's market potential, which is a positive signal compared to other companies that often provide more conservative guidance.
• The expansion into Europe with the launch in Germany is a key milestone, as many MS therapies have seen significant sales in the EU market. This is comparable to the launch strategies of other major players in the MS market such as Biogen and Sanofi.
• The development of a subcutaneous formulation of BRIUMVI is a strategic move to compete with other subcutaneous MS therapies, such as Kesimpta, which offers a more convenient administration route than intravenous infusions.

Stakeholder Impact

• Shareholders will likely react positively to the strong sales and increased revenue guidance.
• Employees may benefit from the company's growth and expansion.
• Patients with MS will have increased access to BRIUMVI and potentially more convenient treatment options.
• Suppliers and partners may see increased business opportunities due to the company's growth.

Next Steps

• Commence clinical development of subcutaneous BRIUMVI.
• Commence a clinical trial evaluating BRIUMVI in an additional autoimmune disease outside of MS.
• Commence a clinical 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, MS, autoimmune disease, CAR T therapy, azer-cel, biopharmaceutical, revenue, clinical trial, commercialization