8-K: TG Therapeutics Reports Strong Q4 and Full Year 2024 Results, BRIUMVI Sales Soar

TG Therapeutics announces positive Q4 and full year 2024 financial results, driven by strong BRIUMVI sales and provides revenue guidance for 2025.

Summary

• TG Therapeutics reported Q4 and full year 2024 financial results, highlighting significant growth driven by BRIUMVI sales.
• BRIUMVI U.S. net product revenue reached $103.6 million for Q4 and $310 million for the full year 2024, representing approximately 250% year-over-year growth.
• The company obtained three additional patents for BRIUMVI, extending patent protection through 2042.
• BRIUMVI has launched in Europe with partner Neuraxpharm and is commercially available in several EU countries and the UK.
• Five-year data from the ULTIMATE I & II Phase 3 trials showed 92% of patients were free from disability progression after five years of BRIUMVI treatment.
• The company launched a Phase 1 trial evaluating subcutaneous ublituximab in patients with relapsing forms of multiple sclerosis (MS).
• TG Therapeutics entered into a global license agreement with Precision BioSciences for the development and commercialization of azer-cel for autoimmune disorders and launched a Phase 1 trial in primary progressive multiple sclerosis.
• The company targets approximately $540 million in total global revenue for 2025, including approximately $525 million from BRIUMVI U.S. net product revenue.
• Full year 2025 target operating expense is approximately $300 million (excluding non-cash compensation).
• Product revenue, net was approximately $107.3 million and $313.7 million for the three and twelve months ended December 31, 2024, respectively, compared to $43.1 million and $92.0 million for the three and twelve months ended December 31, 2023, respectively.
• License, milestone, royalty and other revenue was approximately $0.8 million and $15.3 million for the three and twelve months ended December 31, 2024, respectively, compared to $0.8 million and $141.7 million for the three and twelve months ended December 31, 2023, respectively.
• Net income was $23.3 million and $23.4 million for the three and twelve months ended December 31, 2024, respectively, compared to a net loss of ($14.4) million for the three months ended December 31, 2023 and net income of $12.7 million for the twelve months ended December 31, 2023, respectively.
• Cash, cash equivalents and investment securities were $311.0 million as of December 31, 2024.

Sentiment

Score: 8

Explanation: The document presents a positive outlook with strong financial results, successful commercialization of BRIUMVI, and promising pipeline developments. The company's revenue guidance for 2025 and strong cash position further contribute to the positive sentiment.

Positives

• Strong growth in BRIUMVI sales indicates successful commercialization and market adoption.
• Extended patent protection for BRIUMVI provides long-term revenue potential.
• Positive long-term clinical data supports the efficacy and safety of BRIUMVI.
• The company is expanding its pipeline with subcutaneous ublituximab and azer-cel.
• The company is targeting $540 million in total global revenue for 2025.
• The company reported net income for both the quarter and full year 2024.
• The company has a strong cash position of $311.0 million as of December 31, 2024.

Negatives

• License, milestone, royalty and other revenue decreased significantly from $141.7 million in 2023 to $15.3 million in 2024, primarily due to the recognition of a one-time upfront payment from Neuraxpharm in 2023.
• The company anticipates that its cash, cash equivalents and investment securities as of December 31, 2024, combined with the projected revenues from BRIUMVI, will be sufficient to fund its business based on its current operating plan.

Risks

• The company's ability to achieve its revenue targets depends on continued market acceptance and commercial success of BRIUMVI.
• Regulatory challenges and post-approval compliance obligations could impact the commercialization of BRIUMVI.
• Reliance on third parties for manufacturing, distribution, and supply of BRIUMVI poses a risk to meeting market demand.
• Clinical experience in the post-marketing setting may differ from that demonstrated in controlled clinical trials.
• The company may not achieve its 2025 development pipeline anticipated milestones in the timeframe projected or at all.

Future Outlook

The company targets approximately $540 million in total global revenue for 2025, including approximately $525 million from BRIUMVI U.S. net product revenue, and full year 2025 target operating expense of approximately $300 million (excluding non-cash compensation).

Management Comments

• Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, 2024 was a year of significant outperformance and growth for TG, highlighted by the strong adoption of BRIUMVI for adult patients with relapsing forms of multiple sclerosis, which surpassed our initial expectations.
• Additionally, we made meaningful progress in strengthening our BRIUMVI patent portfolio through 2042, launching new clinical trials, including for subcutaneous BRIUMVI, and advancing our pipeline.
• These accomplishments provide a solid foundation as we look toward continued success in 2025.

Industry Context

The announcement reflects the growing market for MS treatments and the increasing competition among pharmaceutical companies in this space. BRIUMVI competes with other B-cell depleting therapies like Ocrevus (Roche) and Kesimpta (Novartis). The focus on subcutaneous administration and novel CAR T therapies indicates a trend towards more convenient and personalized treatments.

Comparison to Industry Standards

• BRIUMVI's 250% year-over-year growth in U.S. sales indicates a strong market uptake, potentially exceeding the initial launch trajectories of some competing MS drugs.
• The five-year data showing 92% of patients free from disability progression is competitive with long-term data from other MS therapies like Ocrevus and Tysabri.
• The development of subcutaneous ublituximab aligns with the industry trend towards more convenient administration routes, similar to the development of subcutaneous formulations of other biologics.
• The partnership with Precision BioSciences to develop azer-cel positions TG Therapeutics in the emerging field of CAR T therapy for autoimmune disorders, similar to efforts by companies like Kyverna Therapeutics and Cabaletta Bio.

Stakeholder Impact

• Shareholders will benefit from the company's strong financial performance and growth prospects.
• Patients with MS will have access to a new treatment option with proven efficacy and a potentially more convenient subcutaneous formulation.
• Employees will benefit from the company's continued success and expansion.
• The company's partnerships with Neuraxpharm and Precision BioSciences will create value for both companies and their stakeholders.

Next Steps

• Commence pivotal program of subcutaneous ublituximab.
• Commence a pivotal program based on data from the ENHANCE trial with the goal of enhancing the patient experience on intravenous BRIUMVI.
• Enroll participants into the ongoing trial evaluating BRIUMVI in autoimmune diseases outside of MS.
• Enroll participants into the Phase 1 azer-cel trial in autoimmune disease, beginning with progressive forms of MS.
• Present updated data at major medical conferences throughout the year.

Key Dates