Autolus Therapeutics plc Q3 FY2025 earnings call

• Successful launch of Obe-cel in the U.S. for relapsed refractory ALL, with $21.1 million in Q3 net sales and $51 million in nine-month sales. Achieved 60 treatment centers by year-end, with over 90% of U.S. covered lives having patient access. Manufacturing success rate well above 90%. • Leadership team changes: Miranda Neville as chief technology officer, Cynthia Pigina as U.S. chief commercial and country manager, Patrick Milveni as chief accounting officer. Thanks to outgoing leaders Dave Brochu, Brent Rice, and Andrew Mercika for their contributions. • Focus on optimizing operations to drive efficiencies, with plans to innovate in manufacturing, technology, automation, and market access. Expanding into new indications: pediatric B ALL (CATALUS study), lupus nephritis (LUMINA study), and progressive multiple sclerosis (BOBCAT study). • Data presentations at ASH including phase one experience from pediatric study, expanded data from Carlyle study in SLE, and analyses from Felix study on product profile and CAR T cell persistence.

In the third quarter of 2025, product revenue for Obe-cel was $21.1 million. For the first nine months ended September 30, 2025, sales for Obe-cel totaled $51 million. Deferred revenue at the end of Q3 was $7.6 million. Obe-cel is the primary product segment, with these figures representing its financial performance in the quarter and nine-month period.

• Expect key data points from pediatric study and SLE Carlyle study at ASH. Starting of LUMINA trial in lupus nephritis and ALARIC trial in light chain patients before year-end. • Focus on driving market share in adult ALL, improving margins, and expanding beyond ALL into other indications.

• Risks associated with forward-looking statements including actual results differing from expectations due to various uncertainties. • Market risks related to CAR T market penetration and competition. • Regulatory uncertainties in clinical trials and approvals. • Operational risks in manufacturing, supply chain, and commercialization affecting product delivery and sales.

Q: Can you talk about patient flow and anticipated patient flow for Obe-cel, and proportion of patients who might have switched from other therapies to Obe-cel?

A: We have a good proportion of patients not initially considered for CAR T therapy, seeing expansion of market penetration. Encouraged by deferred revenue indicating healthy patients ready for infusion in Q4.

Q: How is Obe-cel positioned competitively in pediatric patients compared to adult relapsed refractory patients?

A: Focus on high-risk pediatric patients with limited options. Obe-cel has a good safety and efficacy profile in children, with consistent access to product being critical. Physician interest supports the move into pediatric setting.

Q: Discuss 3Q over 2Q performance of Obe-cel, sales seasonality, and gross margins?

A: CMS reimbursement policy change impacted Q2 and early Q3 patient enrollment, affecting Q3 sales. Deferred revenue in Q3 indicates healthy patients for Q4. COGS includes depreciation, noncash stock-based comp, and commercial milestone amortization, with plans to improve margins as volumes increase and operations optimize.

Q: Talk about CAR T share growth, frontline consolidation use, and positioning in autoimmune diseases?

A: CAR T penetration in relapsed refractory adult ALL at centers is ~20%, with opportunity to grow in current centers. Physicians considering investigator-sponsored trials in frontline settings. In autoimmune diseases, Obe-cel shows positive safety and efficacy in SLE, positioned against more severe patients with unmet needs.

Q: Color on data expected at ASH?

A: Pediatric study poster with longitudinal data, Carlyle study oral presentation with expanded data, Felix study analyses on product profile and CAR T cell persistence, and Rocket Consortium presentations on real-world experience of Obe-cel.

Q: Regulatory dialogue and timelines for pediatric pivotal trial?

A: Reviewed Phase I data with FDA, designed trial with COG. Starting phase two of pediatric study, expecting data in 2027 or early 2028. Total market opportunity for adult and pediatric ALL is ~1000 patients globally.

Q: Obe-cel dynamics for remainder of 2025, capital trajectory for 2026?

A: CMS impact led to flat Q3 performance, with Q4 dynamics hard to predict as it's first year of launch. Focus on learning curve and market dynamics in Q4. Capital will be used for launch, commercialization, and trial data generation in 2026.

Q: Deferred revenue and gross margin trends?

A: Deferred revenue due to timing between product shipment to centers and patient infusion. COGS noisy initially, expecting margin improvement as volumes increase and operations optimize over time.