ISELIN, N.J. — December 19, 2025 — Leads & Copy —
Outlook Therapeutics, Inc. (Nasdaq: OTLK) has released its financial results for fiscal year 2025, reporting a net loss attributable to common stockholders of $62.4 million, or $1.79 per basic and diluted share, and $1.4 million of revenue.
These results compare with a net loss attributable to common stockholders of $75.4 million, or $4.06 per basic and diluted share, and no revenue for the prior year.
Revenue for fiscal year 2025 consisted of initial sales in June 2025 into sales channels in Germany and the UK for LYTENAVA™ (bevacizumab gamma), where the product title has transferred to the distributor. The company noted a sustained increase in both the number of accounts ordering LYTENAVA™ and the breadth of prescribing clinicians across both markets during the early stages of fiscal year 2026.
Recent developments that should contribute to continued improvements in unit sales include LYTENAVA™ acceptance into the tender framework in the UK in December 2025 and the initiation of a multi-center non-interventional study in Germany to gather real-world data. Gross profit for fiscal 2025 was negatively impacted due to increased reserves for short-dated inventory included in the original shipments to the UK in June 2025.
Overall expenses in fiscal 2025 were $4.6 million lower than in fiscal 2024, primarily due to a significant reduction in R&D expenses associated with the completion of the NORSE Eight clinical trial in fiscal 2024. The reduction in R&D expenses was partially offset by increased SG&A expenses primarily related to launching LYTENAVA™ in Europe in June 2025.
As of September 30, 2025, Outlook Therapeutics had cash and cash equivalents of $8.1 million, which does not include $14.9 million of net proceeds from sales under its at-the-market offering program after September 30, 2025.
Bob Jahr, Chief Executive Officer of Outlook Therapeutics, said the team has worked to position the company for success and is preparing for potential approval and progressing commercial launch activities in the U.S., awaiting a decision from the FDA. He added that commercial activities remain ongoing as the company pushes ahead with efforts to expand into the next wave of country launches, including Austria and the Netherlands.
The U.S. Food and Drug Administration (FDA) PDUFA goal date for ONS-5010 is December 31, 2025.
ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD.
In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. In certain European Union Member States, ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold.
Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells.
Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.
Outlook Therapeutics is focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) to enhance the standard of care for bevacizumab for the treatment of retina diseases.
LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK as a treatment for wet AMD.
In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. If approved in the United States, ONS-5010/LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
OTLK@jtcir.com
Source: Outlook Therapeutics, Inc.
