Autolus Therapeutics Plc Q1 FY2025 earnings call

• AUCATZYL launch off to a good start with $9M revenue in Q1, 39 centers authorized, and ~90% of US medical lives covered. • Plan to expand to ~60 centers in the US by year-end. • Received conditional marketing authorization from MHRA in UK, progressing with NICE and others. • EU market authorization decision expected in second half of 2025, planning launch in Germany first. • Opportunities in frontline consolidation in acute lymphoblastic leukemia, pediatric population, and autoimmune diseases like lupus nephritis and progressive multiple sclerosis. • Phase 1 CARLYSLE study in SLE showed promising early results with quick improvement in inflammatory processes and good safety profile. • Plan to present initial data from pediatric study by end of 2025 and update CARLYSLE study in Q4 2025.

The key product segment is AUCATZYL. In the first quarter of 2025, recognized revenue from AUCATZYL was $9 million. As of April 1, CMS published codes for in and outpatient use, enhancing reimbursement eligibility. The company aims to increase the number of centers delivering AUCATZYL to ~60 in the US, covering ~90% of patients.

• Expect to update on longer-term follow-up from FELIX study towards end of second quarter. • Anticipate EU market authorization notification for relapsed/refractory adult ALL in second half of 2025. • Plan to present initial data from pediatric study PY1 by end of 2025. • Update CARLYSLE study data in fourth quarter 2025. • Expect first patient dosed for Phase 2 lupus nephritis study and progressive MS Phase 1 study in second half/end of 2025. • Continue with AUTO8 program in light chain amyloidosis Phase 1 trial.

• Potential impact of tariffs on product manufacturing and sales. • Revenue recognition implications from CMS April 1 coding update, with evaluation ongoing. • Uncertainties in regulatory approval processes and clinical trial outcomes, including variability in patient dosing timelines and comorbidities affecting treatment. • Risks associated with competitive landscape and market adoption of CAR T products.

Q: For the April 1 coding update for AUCATZYL and $18 million of COGS, when is revenue recognized?

A: Rob Dolski explained current guidance was full recognition upon first administration, but CMS split coding and billing into two administrations effective April 1, with evaluation ongoing for revenue recognition impact.

Q: Any color on AUCATZYL potential exposure to UK or pharma-specific tariffs?

A: Christian Itin noted tariffs on patient cells are typically excluded, but details on UK-US tariff deal and customs value implications are uncertain.

Q: Any chance FDA revisiting pivotal trial design for lupus?

A: Christian Itin said it's uncertain as changes in FDA leadership are not yet clear, but medical need will be a factor.

Q: Quantify Tecartus revenue contribution from B-ALL?

A: Christian Itin said it's difficult to quantify as labels and competitive dynamics make split between indications unclear.

Q: Expected enrollment and follow-up for lupus Phase 2 trial?

A: Christian Itin said Phase 2 expected to enroll ~30 patients, with a year follow-up considered reasonable for meaningful readout.