Autolus Therapeutics (AUTL) Q4 2025 earnings summary

Executive summary

• Achieved $74.3 million in net product revenue for AUCATZYL in its first full year of U.S. launch, with 67 centers activated by year-end 2025 and positive physician feedback on product delivery.

• Regulatory approvals secured in the EU and U.K., with market access and launch initiated in the U.K. at the start of 2026 after a positive NICE evaluation.

• Real-world data from the ROCCA consortium showed a 92% complete remission rate, high clinical activity, and a safety profile consistent with clinical trials, with no high-grade CRS and improved outcomes compared to pivotal trial.

• Expanding clinical programs for obe-cel into pediatric ALL, lupus nephritis, and progressive MS, with pivotal and Phase 2 studies underway and initial data from the BOBCAT trial in MS expected by year-end 2026.

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

Financial highlights

• Net product revenue for Q4 2025 was $23.3 million; total 2025 revenue reached $74.3 million.

• Q4 2025 total revenue, including a $1 million milestone from Moderna, was $24.3 million.

• Cost of sales in Q4 2025 was $25.3 million, up from $11.4 million in Q4 2024, reflecting full commercial activity and inventory adjustments.

• 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.

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.

• Multiple clinical milestones expected in 2026–2028, including pivotal trial data in pediatric B-ALL and lupus nephritis.