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Outlook Therapeutics (OTLK) investor relations material

Outlook Therapeutics Q4 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q4 2025 earnings summary19 Dec, 2025

Executive summary

  • Fiscal 2025 net loss attributable to common stockholders was $62.4 million, or $1.79 per share, on $1.4 million in revenue, compared to a $75.4 million net loss and no revenue in the prior year.

  • Initial commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK began in June 2025, with growing account and clinician adoption into early fiscal 2026.

  • Awaiting FDA decision for U.S. approval of ONS-5010/LYTENAVA™, with a PDUFA goal date of December 31, 2025.

Financial highlights

  • Revenue for fiscal 2025 was $1.4 million, reflecting first sales in Germany and the UK; no revenue was reported in fiscal 2024.

  • Net loss improved to $62.4 million from $75.4 million year-over-year.

  • Gross profit was negatively impacted by increased reserves for short-dated inventory in the UK.

  • R&D expenses decreased significantly due to completion of the NORSE Eight clinical trial, partially offset by higher SG&A expenses for the European launch.

  • Cash and cash equivalents at September 30, 2025, were $8.1 million, not including $14.9 million in net proceeds from an at-the-market offering after year-end.

Outlook and guidance

  • Preparing for potential U.S. commercial launch pending FDA approval, with ongoing expansion efforts in Europe, including Austria and the Netherlands.

  • LYTENAVA™ accepted into the UK tender framework in December 2025 and a real-world data study initiated in Germany.

  • Continued focus on expanding market access and pricing at national and sub-national levels in Europe.

US launch preparations post-FDA decision
Impact of short-dated inventory on EU sales
Cash runway with planned US/EU expansion
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Frequently asked questions

Outlook Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing and launching innovative treatments for ocular diseases. The company is currently working on ONS-5010 / LYTENAVA™ (bevacizumab-vikg), aiming to make it the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal conditions such as wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and branch retinal vein occlusion (BRVO). The company is headquartered in Iselin, New Jersey, and its shares are listed on the Nasdaq.

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