Loading...
•
Sep 30, 2021
Outlook Therapeutics Q4 2021 Earnings Report
Reported financial results for fiscal year 2021 and provided a corporate update.
Key Takeaways
Outlook Therapeutics reported a net loss attributable to common stockholders of $53.2 million for the fiscal year ended September 30, 2021. The company had cash and cash equivalents of $14.5 million at the end of the fiscal year and completed a $57.5 million gross proceeds equity offering subsequent to the fiscal year end.
Successfully completed the registration clinical trials for ONS-5010.
Reported statistically significant and clinically relevant data from clinical trials.
Plans to submit a new BLA under the Public Health Service Act (PHSA) 351(a) regulatory pathway in the first quarter of calendar 2022.
Began commercial launch planning for ONS-5010, including manufacturing, distribution, sales force planning, and engagement with physicians and payors.
Forward Guidance
Outlook Therapeutics anticipates potential FDA approval in 2022 for ONS-5010 and expects to initiate registration clinical trials for ONS-5010 for DME and BRVO in 2023 if FDA approval is received for the wet AMD indication.
Positive Outlook
- Potential FDA approval of ONS-5010 in the first quarter of calendar 2023, resulting in 12 years of marketing exclusivity.
- Plans to file a supplementary application for approval to provide the product in a pre-filled, silicone-free syringe.
- Collaborative discussions with payors and the retina community commenced.
- Developing registration documents for approvals in Europe.
- Exploring potential strategic commercialization partners.
Challenges Ahead
- Risks associated with developing pharmaceutical product candidates.
- Risks of conducting clinical trials.
- Risks in obtaining necessary regulatory approvals.
Historical Earnings Impact
Analyze how earnings announcements historically affect stock price performance
Avg. Return Before/After Earnings
Loading earnings performance data...
Loading earnings reaction data...