TG Therapeutics (TGTX) Q3 2024 earnings summary

Executive summary

• Achieved Q3 2024 Briumvi net sales of $83.3 million, up 15% sequentially and over 230% year-over-year, with continued profitability and strong commercial launch momentum.

• Briumvi is now approved and launched in the US, EU, and UK for relapsing forms of multiple sclerosis, with ex-US commercialization through Neuraxpharm.

• Long-term data from ULTIMATE I/II and ENHANCE trials reinforce Briumvi's efficacy, safety, and convenience, supporting its best-in-class positioning.

• The company is advancing its pipeline, including a Phase 1 trial for subcutaneous ublituximab and IND clearance for azer-cel in progressive MS.

• Commercial infrastructure and patient awareness investments are increasing to support further growth.

Financial highlights

• Q3 2024 Briumvi net product revenue was $83.3 million; nine-month revenue reached $206.4 million.

• Total Q3 2024 revenue was $83.9 million, down from $165.8 million in Q3 2023 due to a one-time $140 million license payment in 2023.

• GAAP net income for Q3 2024 was $3.9 million ($0.02–$0.03 per diluted share), compared to $113.9 million in Q3 2023.

• Cash, cash equivalents, and investment securities totaled $341 million as of September 30, 2024.

• Operating expenses (OpEx), excluding non-cash items, were $50 million for Q3 and $155 million for the first nine months; R&D and SG&A expenses increased year-over-year.

Outlook and guidance

• Full-year 2024 Briumvi net US sales guidance raised to $300–$305 million, up from original $220–$260 million.

• Management expects existing cash and projected Briumvi revenues to fund operations for at least 12 months.

• Continued sequential growth expected into Q4 and 2025, with potential for accelerating new patient starts as commercial efforts expand.

• Investments in marketing, patient awareness, and clinical programs to support blockbuster ambitions.

• Anticipated milestones include new clinical trials for Briumvi in additional autoimmune diseases and azer-cel in progressive MS.