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Sep 30, 2024
Outlook Therapeutics Q4 2024 Earnings Report
Outlook Therapeutics reported financial results for fiscal year 2024 and provided a corporate update.
Key Takeaways
Outlook Therapeutics reported a net loss of $75.4 million for the fiscal year ended September 30, 2024, compared to a net loss of $59.0 million for the prior fiscal year. The company had cash and cash equivalents of $14.9 million as of September 30, 2024. They are preparing for commercial launch in the UK and Germany, expected in the first half of calendar 2025, and plan to resubmit the BLA in the first quarter of calendar 2025.
Received Marketing Authorization for LYTENAVAâ„¢ in the EU and the UK for wet AMD treatment.
National Institute for Health and Care Excellence (NICE) recommended LYTENAVAâ„¢ as an option for treating wet AMD.
Plans for a potential 2025 launch in the UK and Germany are ongoing.
Plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025.
Forward Guidance
Outlook Therapeutics is preparing for the commercial launch of LYTENAVAâ„¢ in the UK and Germany in the first half of calendar 2025 and plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025.
Positive Outlook
- Potential launch of LYTENAVAâ„¢ in the UK and Germany in the first half of calendar 2025.
- Plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025.
- LYTENAVAâ„¢ has an initial 10 years of market exclusivity in the EU and UK.
- Strategic collaboration with Cencora to support the commercial launch of LYTENAVAâ„¢ globally.
- Direct commercialization planned in the EU and the UK, with assessment of licensing and partnering options.
Challenges Ahead
- ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 in the NORSE EIGHT trial.
- Resubmission of the BLA is contingent on positive month 3 efficacy and safety results from NORSE EIGHT.
- Commercial launch is subject to regulatory approvals and market access.
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