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Dec 31, 2022
Outlook Therapeutics Q1 2023 Earnings Report
Reported financial results for the first quarter of fiscal year 2023 and provided a corporate update.
Key Takeaways
Outlook Therapeutics reported a net loss attributable to common stockholders of $18.7 million, or $0.08 per basic and diluted share, for the fiscal first quarter ended December 31, 2022. The company closed a registered direct equity offering and an unsecured convertible promissory note, resulting in net proceeds expected to support operations past the anticipated FDA approval of ONS-5010.
FDA filing of BLA for ONS-5010 was accepted with a PDUFA date set for August 29, 2023.
MAA review in the EU is underway with a decision date expected in early 2024.
Commercial launch planning is underway in anticipation of potential FDA marketing approval in 2023.
Strategic partnership with AmerisourceBergen was established to increase market access and efficient distribution of ONS-5010.
Forward Guidance
The net proceeds from recent transactions are expected to provide sufficient capital to support operations past the anticipated FDA approval of ONS-5010 in the third calendar quarter of 2023 and into the fourth calendar quarter of 2023.
Historical Earnings Impact
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Avg. Return Before/After Earnings
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