Autolus(US:AUTL)2025-11-12 21:22Financial Performance - For the three months ended September 30, 2025, the company incurred a net loss of $79.1 million, compared to a net loss of $82.1 million for the same period in 2024, with an accumulated deficit of $1,296.4 million as of September 30, 2025[180]. - Product revenue, net for the three months ended September 30, 2025, was $21.1 million, a 100% increase compared to $0 in the same period in 2024[233]. - Total revenue, net for the three months ended September 30, 2025, reached $21.2 million, reflecting a 100% increase from $0 in the prior year[232]. - Net loss for the three months ended September 30, 2025, was $79.1 million, a 4% improvement from a net loss of $82.1 million in the same period in 2024[232]. - Product revenue, net for the nine months ended September 30, 2025, was $51.0 million, with no product revenue in the same period in 2024[244]. - Total revenue, net for the nine months ended September 30, 2025, was $51.1 million, a 406% increase from $10.1 million in 2024[243]. - Net loss for the nine months ended September 30, 2025, was $197.2 million, a 2% increase from a net loss of $193.1 million in 2024[243]. Revenue and Expenses - Cost of sales for the three months ended September 30, 2025, was $28.6 million, with no cost of sales recognized in the same period in 2024[234]. - Cost of sales for the nine months ended September 30, 2025, was $71.0 million, with no cost of sales recognized in the same period in 2024[246]. - Research and development expenses, net decreased by $12.4 million to $27.9 million for the three months ended September 30, 2025, a 31% reduction from $40.3 million in 2024[236]. - Research and development expenses, net decreased by $25.5 million to $82.1 million for the nine months ended September 30, 2025, from $107.6 million for the same period in 2024, primarily due to reallocations to cost of sales and a decrease in clinical trial costs[248]. - Selling, general and administrative expenses increased by $9.0 million to $36.3 million for the three months ended September 30, 2025, a 33% increase from $27.3 million in 2024[237]. - Selling, general and administrative expenses increased by $28.7 million to $96.1 million for the nine months ended September 30, 2025, from $67.4 million for the same period in 2024, driven by higher salaries and commercial costs[249]. Cash and Liquidity - As of September 30, 2025, the company had cash and cash equivalents of $86.1 million and marketable securities of $281.3 million, which are expected to fund operations for at least the next twelve months[181]. - Net cash used in operating activities was $216.2 million for the nine months ended September 30, 2025, compared to $168.3 million for the same period in 2024[258]. - As of September 30, 2025, the company had cash and cash equivalents of $86.1 million and available-for-sale debt securities of $281.3 million[257]. Product Development and Regulatory Approvals - The company achieved activation of 60 cancer treatment centers in the United States by November 12, 2025, meeting its target prior to year-end[183]. - AUCATZYL received conditional marketing authorization from the UK MHRA in April 2025, and discussions with NICE for reimbursement are ongoing[183]. - The FDA granted regenerative medicine advanced therapy designation to obe-cel for pediatric patients with r/r B-ALL in October 2025[183]. - The company plans to advance obe-cel into initial clinical development for progressive multiple sclerosis, with the first patient dosed in the Phase 1 BOBCAT trial in October 2025[184]. - The company anticipates no EU sales of AUCATZYL in 2025 and 2026, as the launch in Germany is currently on hold[183]. - The company’s translational programs with University College London continue to support its early-stage pipeline development[192]. Tax and Regulatory Matters - The company has accumulated tax losses for carry forward in the United Kingdom of $545.6 million as of December 31, 2024, with a full valuation allowance against the net deferred tax asset due to uncertain recoverability[230]. - The company may benefit from the United Kingdom "patent box" regime, allowing profits from patents to be taxed at an effective rate of 10% if revenues are generated in the future[231]. - The company has been advised that sales of its obe-cel CAR T therapy in the UK will be considered exempt from VAT, affecting the amount of VAT reclaimed[212]. - The company is subject to state government Medicaid and TriCare programs requiring rebates to be paid to participating state and local government entities[271]. - Pricing on AUCATZYL is extended below list price to entities under the 340B Program, with chargebacks based on the difference between acquisition cost and program price[272]. Accounting and Compliance - The company has experienced increased expenses associated with being a public company, including compliance costs with Nasdaq and SEC requirements[224]. - The company recognizes external development costs based on the progress of specific tasks, including expenses for clinical trials and manufacturing scale-up[209]. - The company recognizes revenue from sales-based royalties at the later of when related sales occur or when the performance obligation is satisfied[204]. - The company tracks direct research and development expenses on a program-by-program basis, primarily consisting of external costs[210]. - There have been no material changes to the company's contractual obligations and commitments as of September 30, 2025[276]. - Recent accounting pronouncements that may impact financial position and results of operations are disclosed in the quarterly report[277]. - The company is considered a "smaller reporting company" and is not required to provide certain market risk disclosures[278].