Autolus(US:AUTL)2025-05-08 20:12Part I – Financial Information Financial Statements The company reported its first AUCATZYL product revenue, a $70.2 million net loss, and increased liabilities for Q1 2025, confirming going concern Condensed Consolidated Balance Sheets Total assets were $746.3 million, liabilities increased to $375.2 million, and equity decreased to $371.1 million as of March 31, 2025 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $95,799 | $227,380 | | Marketable securities | $420,776 | $360,643 | | Inventories, net | $14,647 | $4,138 | | Total assets | $746,338 | $782,725 | | Liabilities & Equity | | | | Total current liabilities | $66,615 | $60,743 | | Liabilities related to future royalties and milestones, net (non-current) | $253,437 | $244,600 | | Total liabilities | $375,230 | $355,400 | | Total shareholders' equity | $371,108 | $427,325 | Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) Q1 2025 saw first product revenue of $9.0 million, with net loss increasing to $70.2 million from $52.7 million in Q1 2024 Q1 2025 vs Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Product revenue, net | $8,982 | $— | | License revenue | $— | $10,091 | | Total revenue, net | $8,982 | $10,091 | | Cost of sales | ($17,951) | $— | | Research and development expenses, net | ($26,734) | ($30,671) | | Selling, general and administrative expenses | ($29,534) | ($18,177) | | Loss from operations | ($65,240) | ($38,757) | | Net loss | ($70,161) | ($52,690) | | Basic and diluted net loss per share | ($0.26) | ($0.24) | Condensed Consolidated Statements of Changes in Shareholders' Equity Shareholders' equity decreased to $371.1 million by March 31, 2025, primarily due to a $70.2 million net loss - Total shareholders' equity decreased by $56.2 million in Q1 2025, mainly driven by the quarterly net loss of $70.2 million26 - In Q1 2024, the company raised net proceeds of $520.6 million from the issuance of ordinary shares26 Condensed Consolidated Statements of Cash Flows Net cash used in operating activities increased to $75.6 million in Q1 2025, with $59.5 million used in investing and no financing activities Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($75,565) | ($40,514) | | Net cash used in investing activities | ($59,547) | ($533) | | Net cash provided by financing activities | $— | $561,441 | - The total cash, cash equivalents, and restricted cash decreased by $131.6 million during Q1 2025, ending the period at $97.3 million2829 Notes to the Unaudited Condensed Consolidated Interim Financial Statements Notes detail the company's commercial transition with AUCATZYL, outlining revenue recognition policies and significant royalty liabilities - AUCATZYL (obe-cel) was approved by the FDA on November 8, 2024, for adult r/r B-ALL, with the U.S. commercial launch in January 2025. U.K. MHRA granted conditional marketing authorization in April 202532 - The company recognized its first product revenue of $9.0 million in Q1 2025, entirely from the U.S. This revenue is recognized when the product is administered to the patient and is net of estimated gross-to-net deductions5577 - Liabilities related to future royalties and milestones from agreements with Blackstone and BioNTech totaled $258.2 million as of March 31, 2025. Interest expense accrued on these liabilities was $10.1 million for the quarter125 - The company has capital commitments of $16.4 million for capital expenditures and $2.9 million for master supply commitments as of March 31, 2025143144 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's commercial transition with AUCATZYL, reporting $9.0 million net product sales and a $70.2 million net loss in Q1 2025 Recent Developments Key Q1 2025 developments include AUCATZYL's U.S. launch, U.K. authorization, and progress in obe-cel clinical trials for LN and MS - Reported Q1 2025 net product sales of $9.0 million for AUCATZYL173 - As of May 7, 2025, 39 U.S. cancer treatment centers are activated, with over 90% of U.S. medical lives having secured coverage for AUCATZYL173 - The U.K. MHRA granted conditional marketing authorization for AUCATZYL on April 25, 2025173 - The company plans to initiate a Phase 2 pivotal trial for obe-cel in lupus nephritis (LN) and a Phase 1 trial in progressive multiple sclerosis (MS) by year-end 2025173171 Results of Operations Q1 2025 total revenue decreased to $9.0 million, with new cost of sales, increased SG&A, and decreased R&D, widening the net loss to $70.2 million Comparison of Operations for Three Months Ended March 31 (in thousands) | Item | 2025 | 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenue, net | $8,982 | $10,091 | ($1,109) | (11)% | | Cost of sales | ($17,951) | $— | ($17,951) | 100% | | R&D expenses, net | ($26,734) | ($30,671) | $3,937 | (13)% | | SG&A expenses | ($29,534) | ($18,177) | ($11,357) | 62% | | Net loss | ($70,161) | ($52,690) | ($17,471) | 33% | - The decrease in R&D expenses was primarily due to a $6.1 million reduction from reallocating IT and support costs and a $2.0 million reduction in personnel costs to commercial manufacturing activities (cost of sales and inventory) following FDA approval222 - The increase in SG&A expenses was driven by a $7.9 million rise in personnel costs from increased headcount and a $1.7 million increase in commercial readiness costs223 Liquidity and Capital Resources As of March 31, 2025, the company held $516.6 million in cash and marketable securities, sufficient for twelve months, with significant future capital needs Cash Position (in millions) | Item | March 31, 2025 | | :--- | :--- | | Cash and cash equivalents | $95.8 | | Available-for-sale debt securities | $420.8 | | Total | $516.6 | - The company believes its existing cash and marketable securities will fund operating expenses and capital requirements for at least twelve months from the report's issuance date237 - Future capital needs will be driven by AUCATZYL commercialization, advancing other product candidates, expanding manufacturing, and hiring additional personnel236238 Quantitative and Qualitative Disclosures About Market Risk The company's primary market risks are interest rate and foreign currency fluctuations, with a 1% interest rate change impacting income by $1.0 million - Primary market risks are interest rate and foreign currency exchange risk252 - A hypothetical one percentage point change in interest rates would have resulted in a $1.0 million change in interest income for Q1 2025253 - As of March 31, 2025, approximately 55% of cash held by the main U.K. subsidiary was in GBP and 40% in USD. The company recorded a foreign exchange gain of $1.2 million in Q1 2025256257 Controls and Procedures Management concluded disclosure controls were effective as of March 31, 2025, with no material changes to internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of March 31, 2025261 - No material changes in internal control over financial reporting occurred during the quarter ended March 31, 2025262 Part II – Other Information Legal Proceedings The company is not currently a party to any material legal proceedings, nor is it aware of any pending or threatened actions - As of the filing date, the company is not a party to any material legal proceedings263 Risk Factors Key risks include government price controls, CMS reimbursement policies delaying AUCATZYL revenue, and international trade policies impacting supply chain and costs - A new CMS policy splits the AUCATZYL dose into two administrations for billing, which may delay the company's and treatment centers' ability to recognize revenue265 - International trade policies, including tariffs and sanctions, pose a risk as the company depends on a global supply chain and manufactures all commercial and clinical supplies in the U.K.267 - The company's ability to pass on increased costs from tariffs is limited by fixed-price contracts with payors, which could negatively impact profitability270 Unregistered Sales of Equity Securities and Use of Proceeds There were no unregistered sales of equity securities during the period - None274 Defaults Upon Senior Securities There were no defaults upon senior securities during the period - None275 Mine Safety Disclosures This item is not applicable to the company - Not applicable276 Other Information No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during Q1 2025 - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during Q1 2025277 Exhibits This section lists exhibits filed with the Quarterly Report on Form 10-Q, including the 2025 Inducement Plan and officer certifications