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Dec 31, 2024
Outlook Therapeutics Q1 2025 Earnings Report
Outlook Therapeutics reported financial results for the first quarter of fiscal year 2025 and provided a corporate update.
Key Takeaways
Outlook Therapeutics reported a net income of $17.4 million, or $0.72 per share, for the fiscal first quarter ended December 31, 2024, compared to a net loss of $11.2 million, or $0.86 per share, for the same period last year. The company is preparing for the potential launch of LYTENAVA™ in Germany and the UK in the second quarter of calendar year 2025 and plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025.
Net income attributable to common stockholders was $17.4 million, or $0.72 per basic and diluted share.
Adjusted net loss attributable to common stockholders was $21.6 million, or $0.89 per basic and diluted share.
Plans for a potential 2025 launch in Germany and the UK are ongoing.
BLA is on track for resubmission this quarter.
Outlook Therapeutics
Outlook Therapeutics
Forward Guidance
Outlook Therapeutics is focused on resubmitting the BLA for ONS-5010 and launching LYTENAVA™ in Europe.
Positive Outlook
- Potential launch of LYTENAVA™ in Germany and the UK in the second quarter of calendar 2025.
- LYTENAVA™ is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the EU and UK.
- Plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025.
- Strategic collaboration with Cencora to support the commercial launch of LYTENAVA™ globally following regulatory approvals.
- NORSE EIGHT data showed that anatomical response was similar between treatments.
Challenges Ahead
- ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 in the NORSE EIGHT clinical trial.
- There are risks associated with developing and commercializing pharmaceutical product candidates.
- Risks of conducting clinical trials and risks in obtaining necessary regulatory approvals.
- Uncertainty of market conditions and future impacts related to macroeconomic factors.
- Fluctuations in interest rates and inflation and potential future bank failures on the global business environment.