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Sep 30, 2022
Outlook Therapeutics Q4 2022 Earnings Report
Announced financial results for fiscal year 2022 and provided a corporate update.
Key Takeaways
Outlook Therapeutics reported a net loss attributable to common stockholders of $66.1 million for the fiscal year ended September 30, 2022. The company had cash and cash equivalents of $17.4 million at the end of the fiscal year.
Fiscal year 2022 laid a solid foundation for a transformational 2023.
Commercialization planning is underway towards expected launch with the accepted FDA filing of BLA for ONS-5010 and PDUFA date set for August 29, 2023.
MAA review in the EU is underway with a decision date expected in early 2024.
Strategic commercialization agreement with AmerisourceBergen to expand reach for connecting to retina specialists and their patients.
Forward Guidance
Outlook Therapeutics anticipates potential FDA approval in August 2023 and continues to explore potential strategic commercialization partners.
Positive Outlook
- Potential FDA approval of ONS-5010 in the third calendar quarter of 2023.
- Submission of a supplementary application (sBLA) for approval to provide the product in a pre-filled, silicone oil liquid-free syringe.
- Developing registration documents on a parallel path for approvals in Europe and submitted them in December 2022.
- Received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials.
- Exploring a relationship with AmerisourceBergen to support the launch of ONS-5010 in international markets.
Challenges Ahead
- Risks associated with developing pharmaceutical product candidates
- Risks of conducting clinical trials
- Risks in obtaining necessary regulatory approvals
Historical Earnings Impact
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