Autolus(AUTL)2024-11-12 21:27Financial Performance - For the three months ended September 30, 2024, the company incurred a net loss of $82.1 million, compared to a net loss of $45.8 million for the same period in 2023, representing an increase of 79.3%[111] - For the nine months ended September 30, 2024, the net loss was $193.1 million, up from $131.2 million in 2023, indicating a year-over-year increase of 47.2%[111] - The net loss for the three months ended September 30, 2024, was $82.1 million, a 79% increase from the net loss of $45.8 million in the same period of 2023[131] - License revenue was $0 for the three months ended September 30, 2024, compared to $0.4 million in the same period of 2023[132] - License revenue for the nine months ended September 30, 2024, was $10.1 million, a 494% increase from $1.7 million for the same period in 2023[142] Cash and Cash Equivalents - As of September 30, 2024, the company had an accumulated deficit of $1,071.6 million, compared to $878.6 million as of December 31, 2023[111] - The company had cash and cash equivalents of $657.1 million as of September 30, 2024, which is expected to fund operations for at least the next twelve months[111] - As of September 30, 2024, the company had cash and cash equivalents of $657.1 million, up from $239.6 million as of December 31, 2023[169] Operating Expenses - Research and development expenses increased by 25% to $40.3 million for the three months ended September 30, 2024, compared to $32.3 million in the same period of 2023[131] - General and administrative expenses surged by 158% to $27.3 million for the three months ended September 30, 2024, up from $10.6 million in the prior year[131] - Total operating expenses rose by 58% to $67.9 million for the three months ended September 30, 2024, compared to $42.9 million in the same period of 2023[131] - General and administrative expenses rose by $36.4 million to $67.4 million for the nine months ended September 30, 2024, compared to $31.0 million for the same period in 2023, marking a 117% increase[145] - Total research and development expenses for the nine months ended September 30, 2024, were $107.6 million, up 16% from $92.9 million for the same period in 2023[144] Interest and Foreign Exchange - Interest income increased by 128% to $8.3 million for the three months ended September 30, 2024, compared to $3.6 million in the prior year[131] - Interest expense rose by 113% to $10.7 million for the three months ended September 30, 2024, up from $5.0 million in the same period of 2023[131] - Foreign exchange losses increased significantly to $11.9 million for the three months ended September 30, 2024, compared to $1.7 million in the same period of 2023, marking a 586% increase[131] - For the nine months ended September 30, 2024, foreign exchange losses were $12.4 million, up from $0.4 million in the same period of 2023[171] - An immediate hypothetical one percentage point change in interest rates would have resulted in a $1.8 million increase in interest income for the nine months ended September 30, 2024[169] Regulatory Approvals and Clinical Trials - The FDA granted marketing approval for AUCATZYL (obe-cel) for adult relapsed/refractory B-cell Acute Lymphoblastic Leukemia on November 8, 2024[112] - The approval of AUCATZYL triggered a $30.0 million milestone payment from Blackstone, resulting in a net increase to cash and cash equivalents of $16.6 million after a £10.0 million regulatory milestone payment[113] - The ongoing Phase 1 trial (CARLYSLE) for obe-cel in refractory systemic lupus erythematosus is expected to complete enrollment and present initial data in Q1 2025[112] - Clinical programs AUTO8, AUTO6NG, and AUTO1/22 are progressing as expected, with data updates planned for 2025[112] Future Outlook and Funding - The company expects significant expenses and operating losses as it markets AUCATZYL and advances other product candidates through development and regulatory approval[151] - The company plans to establish and expand its sales, marketing, and distribution infrastructure for AUCATZYL and other product candidates[159] - Future funding requirements will depend on the commercialization of AUCATZYL and the progress of clinical trials for other product candidates[161] - The company anticipates increased expenses related to hiring additional personnel and expanding infrastructure to support growth[159] Miscellaneous - The company has no revenue from commercial product sales as of September 30, 2024, with total revenue generated from outlicensing agreements[114] - The company has raised an aggregate of $1.7 billion from various capital sources since its inception in 2014 through September 30, 2024[151] - The company does not currently engage in currency hedging activities but may consider it in the future to manage currency exposure[171] - The effective interest rate for the BioNTech Liability may fluctuate due to discretionary contractual payments[169] - The carrying amount of the Blackstone Collaboration Agreement Liability is based on estimated future royalties and milestones[169] - The company maintains its accounting records in pounds sterling and presents consolidated financial statements in U.S. dollars[171] - Changes in exchange rates have caused material fluctuations in the Consolidated Statements of Operations and Comprehensive Loss[171]