Autolus Therapeutics (AUTL) investor relations material

Business performance and commercial highlights

• Lead CD19-targeting CAR-T product launched in the U.S. 18 months ago, with $74M revenue in 2025 and guidance of $120M–$135M for the current year.

• Real-world data from the ROCCA consortium confirmed strong safety and efficacy, with >90% complete remission and low neurological toxicity.

• Product adoption expanding to older and comorbid patients, and those with low disease burden, broadening the eligible population.

• 76 U.S. centers licensed, expected to reach mid-80s by year-end; focus is on deeper penetration within existing centers.

• Majority of physicians reuse the product, driven by safety, efficacy, and operational benefits for hospitals.

Expansion and clinical development

• Investigator-sponsored studies underway for frontline consolidation and use, aiming to replace lengthy chemotherapy regimens.

• Pivotal pediatric study ongoing, with >90% remission and expanded enrollment for potential full approval.

• Active development in autoimmune diseases, including lupus nephritis (LUMINA study) and progressive MS (BOBCAT study), leveraging the product’s ability to cross the blood-brain barrier.

• Substantial new data in SLE expected at ACR later this year; early BOBCAT data in MS expected by year-end, with more robust results next year.

International and health economics

• U.K. launch benefited from NICE approval and immediate NHS access, with centralized physician panel accelerating adoption.

• U.K. per capita CAR-T access higher than U.S.; ex-U.S. sales breakout expected in the second year of launch.

• European pricing and adoption challenged by health economic models that undervalue single-arm study data and exclude infrastructure savings.

• Cell and gene therapies currently excluded from MFN pricing pilot; European expansion is country-specific.