Outlook Therapeutics ( (OTLK) ) has released its Q3 earnings. Here is a breakdown of the information Outlook Therapeutics presented to its investors.
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Outlook Therapeutics, Inc. is a biopharmaceutical company specializing in the development and commercialization of ophthalmic formulations of bevacizumab for treating retinal diseases, particularly wet age-related macular degeneration (AMD).
In its latest earnings report for the third quarter of fiscal year 2025, Outlook Therapeutics announced the first commercial sales of its product, LYTENA V A™ (bevacizumab gamma), in Europe. The company also highlighted the upcoming Prescription Drug User Fee Act (PDUFA) goal date for its U.S. market entry, set for August 27, 2025.
The company reported a net loss attributable to common stockholders of $20.2 million, or $0.55 per share, for the quarter, with $1.5 million in revenue from initial sales in Germany and the UK. This marks an improvement from the previous year’s net loss of $0.89 per share with no revenue. The adjusted net loss was $15.8 million, or $0.44 per share, excluding certain non-cash items.
Outlook Therapeutics is actively preparing for potential FDA approval of ONS-5010, branded as LYTENA V A™ in the U.S., which could make it the first approved ophthalmic formulation of bevacizumab for retinal indications in the country. The company has entered a strategic collaboration with Cencora to support its global commercial launch.
Looking ahead, Outlook Therapeutics is focused on expanding its market presence and achieving regulatory milestones. The company is optimistic about the potential FDA approval and the subsequent commercial opportunities in the U.S. market, which could significantly enhance its growth trajectory.