Autolus Therapeutics Plc Q4 FY2024 earnings call

Key Points from Christian Itin:

• 2024 was successful, setting up well for 2025. Primary objective is successful commercial launch of AUCATZYL. Achieved US approval for obe-cel on Nov 8, ahead of schedule, with a broad label in relapsed refractory ALL for adults and no REMS program. Clinical results published in NEJM in Dec, and included in NCCN guidelines. As of March 19, 33 centers authorized, expecting 60 centers by end of 2024. Focus on expanding obe-cel's utility in autoimmune and hematology, with ongoing studies like CARLYSLE and PY1. Early pipeline activities with partners.

Key Points from Rob Dolski:

• Cash, cash equivalents, and marketable securities at year-end 2024 totaled $588 million, up from $239 million in 2023. Loss from operations in 2024 was $241.4 million. Cost of sales was $11.4 million post BLA approval. R&D expenses increased to $138.4 million. SG&A expenses rose to $101.1 million. Milestones triggered in Q4: $30 million from Blackstone and £10 million regulatory milestone payment.

No detailed breakdown of product segments with revenue contribution percentages provided in the transcript.

Milestones and Guidance:

• Upcoming R&D event on April 23 in New York to outline future growth plans. Expect updates on SL1 CARLYSLE study in April, pediatric study PY1 update in second half of 2025, and long-term follow-up on CARLYSLE study in second half. Anticipate regulatory notifications for UK and EU approvals of obe-cel in second half of 2025.

Risks:

• Forward-looking statements subject to various risks and uncertainties that could cause actual results to differ materially from expectations. Potential impacts from regulatory uncertainties and potential tariff impacts on manufacturing in the UK.

Q: On AUCATZYL launch, any color on initial demand or book of orders? And on outpatient use?

A: Christian Itin said there's a good dynamic around center activation and interest in AUCATZYL, but fuller picture at Q1 update. On outpatient use, safety data shows patients with low tumor burden have limited safety events, and physicians are interested in exploring outpatient administration, but it's early days.

Q: Ramp to 60 authorized centers and impact of tariffs?

A: Christian Itin said ramp of centers has been steady, with a continuous flow, expecting gradual build through the year. On tariffs, very hard to speculate as it's an open question with no visibility currently.

Q: Time from center activation to first patient for AUCATZYL?

A: Christian Itin said it's variable; some centers have short periods, others vary, but early signs are positive with centers getting into repeat mode.

Q: SLE data in upcoming R&D day and resources for launch?

A: Christian Itin said the SLE data will show product properties, safety, and impact on disease scores. Resources for launch are focused on service delivery, including triaging and supporting centers, medical affairs, and market access support, different from conventional sales and marketing.

Q: Adult ALL program treatment adoption and SLE efficacy signals?

A: Christian Itin said first wave of treatment adoption includes centers with and without prior Takeda experience. On SLE, details at R&D day, with study designed to step up or down dose, and focus on product behavior, safety, and B-cell depletion.

Q: Centers onboarded, apheresis, and sales guidance?

A: Christian Itin said top centers are already active, apheresis not guided as it's not clean for reporting, and no sales guidance given for 2025 as it's too early and multiple factors at play.

Q: Vein-to-vein time for AUCATZYL and EU approval preparations?

A: Christian Itin said turnaround time is consistent with expectations, with learnings from initial batches. EU approval process is ongoing, similar to US preparation, with work in progress with clinical centers in the UK and Germany.

Q: NICE timeline for AUCATZYL and CARLYSLE study follow-up?

A: Christian Itin said NICE timeline is ongoing and not pinpointable. For CARLYSLE study, follow-up includes one patient with over 6 months, two with over 3 months, and three with 1-3 months of follow-up, with longer follow-up in second half of 2025.