Outlook Therapeutics reported a net loss of $62.4 million, or $1.79 per share, for the fiscal year ended September 30, 2025, a notable improvement from the $75.4 million loss recorded in 2024. Revenue for the year totaled $1.4 million, driven by the first commercial sales of LYTENAVA™ (bevacizumab gamma) in Germany and the United Kingdom, where the product began shipping on June 2, 2025 and has seen a steady rise in ordering accounts and prescribing clinicians.
The company’s revenue growth was modest because LYTENAVA’s launch is still in its early stages. While the product has secured initial sales, the total revenue of $1.4 million reflects the limited market penetration and the fact that sales are concentrated in only two European countries. The launch has, however, established a foundation for future expansion into Austria and the Netherlands, as management indicated a focus on scaling the commercial footprint across the region.
On the cost side, Outlook reduced research and development expenses by $4.6 million after completing the NORSE Eight clinical trial, a key milestone that supports the BLA resubmission. Nevertheless, selling, general and administrative costs rose due to the European launch, and gross profit was negatively impacted by reserves for short‑dated inventory from UK shipments. These inventory reserves, necessary to meet early demand, created a large negative gross‑profit figure that offset the savings from lower R&D spend.
Cash and cash equivalents stood at $8.1 million as of September 30, 2025, and the company raised an additional $14.9 million in net proceeds from an at‑the‑market offering after that date. With a current ratio of 0.67, Outlook’s liquidity remains constrained, underscoring the need for continued capital infusion or a successful U.S. launch to improve cash flow.
Regulatory developments remain a critical focus. The FDA’s PDUFA goal date for ONS‑5010 is December 31, 2025, and the company is preparing for a potential U.S. launch pending that decision. CEO Bob Jahr emphasized the company’s readiness, stating, “We are preparing now for potential approval and progressing commercial launch activities in the U.S., as we await a decision from the FDA in just a few short weeks.” Senior Vice President Jedd Comiskey added that the European launch will continue to be a priority, noting, “We remain laser focused on ensuring success in Germany and the UK as we prepare for additional launches across the region later this year and throughout 2026.”
Analysts had forecast earnings per share of –$1.34 for the year, so Outlook’s $1.79 loss per share represents a miss. The miss is largely attributable to the combination of high operating costs, inventory reserve charges, and the fact that revenue is still in the early, low‑volume stage of commercialization. Despite the miss, the company’s loss narrowed from the previous year’s $75.4 million, indicating progress toward profitability as commercial operations mature.
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