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Jun 30, 2022
Outlook Therapeutics Q3 2022 Earnings Report
Outlook Therapeutics reported financial results for the third quarter of fiscal year 2022 and reiterated key anticipated near-term milestones.
Key Takeaways
Outlook Therapeutics reported a net loss attributable to common stockholders of $17.5 million, or $0.08 per basic and diluted share, for the fiscal third quarter ended June 30, 2022. The company had cash and cash equivalents of $26.0 million at June 30, 2022, which are expected to provide funding into the first calendar quarter of 2023. The company is focused on resubmitting the BLA for ONS-5010 by September 2022.
Received feedback from the FDA and established a clear path forward for ONS-5010 BLA re-submission, planned for September of this year.
Positioning operationally and financially for the potential FDA approval and subsequent launch of ONS-5010.
Voluntarily withdrew the BLA in May 2022 and is actively working to provide supplemental information that the FDA has requested.
Began commercial launch planning in anticipation of potential FDA marketing approval in 2023.
Outlook Therapeutics
Outlook Therapeutics
Forward Guidance
Outlook Therapeutics expects to resubmit the BLA for ONS-5010 by September 2022 and is developing registration documents for approvals in Europe, expected to be submitted in the fourth quarter of calendar 2022. The company's cash and cash equivalents on hand are expected to provide funding into the first calendar quarter of 2023.
Positive Outlook
- Clear path forward for ONS-5010 BLA re-submission.
- Potential FDA approval and subsequent launch of ONS-5010.
- Developing registration documents for approvals in Europe, expected to be submitted in the fourth quarter of calendar 2022.
- Building out distribution and commercial team structures.
- Collaborative discussions with payors and the retina community.
Challenges Ahead
- Net loss attributable to common stockholders of $17.5 million for the fiscal third quarter ended June 30, 2022.
- Voluntarily withdrew the BLA in May 2022.
- Cash and cash equivalents on hand are expected to provide funding only into the first calendar quarter of 2023.
- Reliance on potential FDA approval and commercial launch of ONS-5010.
- Risks associated with developing pharmaceutical product candidates and obtaining necessary regulatory approvals.