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Autolus Therapeutics (AUTL) investor relations material
Autolus Therapeutics Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Executive summary
Achieved $20.9M in Q2 2025 US product sales for AUCATZYL, with 46 US centers activated and over 90% coverage of US medical lives, driven by strong demand and positive physician feedback.
Conditional marketing authorizations received in the UK and EU in Q2 2025, but no EU sales expected in 2025-2026 due to pricing, reimbursement, and orphan status challenges.
Long-term FELIX study data presented at EHA 2025 showed durable responses and favorable safety for AUCATZYL in r/r B-ALL, with 38.4% of responders in ongoing remission at 32.8 months median follow-up.
Pipeline advancing with pivotal trials in lupus nephritis and first-in-human progressive MS trial expected to start by year-end 2025.
Real-world data and clinical trial progress support further market access and label expansion efforts.
Financial highlights
Q2 2025 net product revenue was $20.9M; six months ended June 30, 2025, revenue totaled $29.9M.
Cost of sales in Q2 2025 was $24.4M, including deferred revenue and royalties; gross margin remained negative.
R&D expenses decreased to $27.4M in Q2 2025 (down from $36.6M YoY); SG&A expenses rose to $30.3M (from $21.9M YoY) due to commercialization.
Net loss for Q2 2025 was $47.9M, improved from $58.3M YoY; basic and diluted net loss per share was $(0.18) versus $(0.22) in Q2 2024.
Cash, cash equivalents, and marketable securities totaled $454.3M at June 30, 2025, down from $588M at year-end, impacted by operating cash use and delayed R&D tax credit.
Outlook and guidance
No EU sales expected in 2025-2026; focus remains on disciplined, country-by-country market access and pricing negotiations.
Pivotal trials in lupus nephritis and progressive MS expected to initiate by year-end 2025; SLE Phase 1 and pediatric ALL data anticipated in H2 2025.
Cash and marketable securities expected to fund operations for at least 12 months from issuance; management believes resources are sufficient for near-term objectives.
US center expansion to 60+ targeted by year-end, with CMS-related enrollment impacts expected to resolve by Q4.
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