Autolus Therapeutics plc Q2 FY2025 earnings call

• Obe-cel launch had $20.9M in Q2 sales, $29.9M first six months. 46 centers authorized in US, 90% US medical lives covered. CMS split reimbursement impacted revenue recognition and patient enrollment, expected resolved by Q4. - Regulatory filings: UK conditional marketing auth in April, EU Commission approval in July. Working on UK market access with NICE, EU country-by-country evaluation. - Felix data: 32.8 months median follow-up, 38% in remission, median response duration 42.6 months, overall survival plateau at ~40% beyond two years. - OviCel development: Expanding beyond adult relapsed/refractory ALL, pediatric study PY1, Phase II lupus nephritis study starting, Phase I MS study open.

In the second quarter, net product revenue was $20.9 million, up from $9 million in the first quarter. Cost of sales totaled $24.4 million. Research and development expenses decreased to $27.4 million from $36.6 million in the same period in 2024. Selling, general and administrative expenses increased to $30.3 million from $21.9 million. Loss from operations was $61.2 million. Net loss was $47.9 million. Cash, cash equivalents, and marketable securities at Q2 2025 were $454.3 million. Obe-cel generated $20.9 million in Q2 sales, with first six months at $29.9 million. 46 centers authorized in US, aiming for 60+ by year-end. Regulatory filings in UK and EU, with no EU sales expected in 2025/2026. Felix data showed favorable median follow-up and survival.

• Aim to reach 60+ authorized centers for Obe-cel by year-end. - Update Felix data at EHA, present Phase I SLE data at ACR in Oct, review pediatric ALL Phase I data by year-end. - Start dosing in lupus nephritis Phase II, MS Phase I, and AUTO8 amyloidosis studies in second half.

• Market access challenges in Europe due to methodological differences in assessing rare diseases based on single-arm studies. - Disconnect between healthcare infrastructure costs covered by taxes and therapeutic costs assessed by payers, affecting value assessment. - Uncertainty in EU launch timelines and reimbursement negotiations impacting sales projections.

Q: Was Germany launch originally a green light but flipped due to pricing/reimbursement changes?

A: Market access in Europe for cell and gene therapies is challenged by reliance on randomized controlled study data for single-arm based programs, leading to methodological disjointedness. We'll navigate country-by-country methodically.

Q: Once split reimbursement is absorbed, will enrollment and sales accelerate?

A: Split reimbursement change impacted patient enrollment, adjustments made in Q2, expected resolved by Q4, with enrollment and sales expected to accelerate thereafter.

Q: How is Obe-cel received in US community?

A: Reception is positive, with early reorders at centers due to good safety profile and manageability.

Q: Will patients travel from neighboring countries for Obe-cel in UK?

A: Medical tourism to UK for cell therapies is possible, similar to other complex therapies, and Obe-cel's profile may permit this, though dependent on insurance and payer clearances.

Q: What data points expected in SAR presentation for autoimmune?

A: Key data from longer follow-up of SLE patients, earlier data from enrolled patients, and analysis of pharmacodynamics and translational data in lupus nephritis and MS studies.