Outlook Therapeutics(US:OTLK)2025-12-19 13:30Financial Performance - For the fiscal year ended September 30, 2025, Outlook Therapeutics reported a net loss of $62.4 million, or $1.79 per share, compared to a net loss of $75.4 million, or $4.06 per share, in the prior year[3]. - Revenue for fiscal 2025 was $1.4 million, attributed to initial sales of LYTENAVA™ in Germany and the UK, marking a significant increase in accounts ordering the product[4]. - Gross profit for fiscal 2025 was $57, negatively impacted by increased reserves for short-dated inventory from initial shipments[16]. - Research and development expenses decreased by $14.6 million to $27.2 million in fiscal 2025, primarily due to the completion of the NORSE Eight clinical trial[5]. - Selling, general and administrative expenses increased to $39.9 million in fiscal 2025, up from $29.9 million in the previous year, mainly related to the launch of LYTENAVA™[16]. - Total stockholders' deficit improved to $(32.2) million as of September 30, 2025, compared to $(73.1) million in the previous year[18]. Market Expansion - As of September 30, 2025, cash and cash equivalents were $8.1 million, not including $14.9 million from recent sales under the at-the-market offering program[6]. - Outlook Therapeutics is preparing for further market expansion into Austria and the Netherlands following initial launches in Germany and the UK[6]. - The company aims to provide access to an approved ophthalmic formulation of bevacizumab, enhancing treatment options for retinal diseases[11]. Regulatory Milestones - The FDA PDUFA goal date for ONS-5010 is set for December 31, 2025, indicating a potential approval timeline for the U.S. market[7].