Autolus Therapeutics (AUTL) Q4 2025 earnings summary

Executive summary

• Net product revenue for AUCATZYL reached $74.3 million in 2025, with $23.3 million in Q4, driven by strong U.S. launch and 67 activated centers by year-end; UK launch began in January 2026 after regulatory approval.

• Real-world data from the ROCCA consortium showed high clinical activity, a 92% complete remission rate, and a favorable safety profile consistent with clinical trials.

• Expansion of clinical programs for obe-cel into pediatric ALL, lupus nephritis, and progressive MS, with pivotal and Phase 2 trials enrolling and initial data expected in 2026–2028.

• RMAT designation granted by FDA for obe-cel in pediatric r/r B-ALL in October 2025.

Financial highlights

• Q4 2025 net product revenue was $23.3 million; full year 2025 revenue totaled $74.3 million.

• Cost of sales in Q4 2025 was $25.3 million, up from $11.4 million in Q4 2024, reflecting higher sales and manufacturing expenses.

• R&D expenses rose to $35.6 million in Q4 2025, and SG&A expenses increased to $35.8 million.

• Net loss for Q4 2025 was $90.3 million, compared to $27.6 million in Q4 2024; cash and equivalents at year-end 2025 totaled $300.7 million, down from $588 million at end of 2024.

• Loss from operations for Q4 2025 was $72.5 million; total comprehensive loss was $90.8 million.

Outlook and guidance

• 2026 net revenue guidance for AUCATZYL is $120 million–$135 million, with a shift to positive gross margins expected due to higher volumes and operational efficiencies.

• Commercial footprint to expand to over 80 activated centers by end of 2026.

• Current cash and projected revenues expected to fund operations into Q4 2027.

• No significant revenue expected from EU countries outside the U.K. in 2026.