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Mar 31, 2022
Outlook Therapeutics Q2 2022 Earnings Report
Outlook Therapeutics reported a net loss and focused on pre-commercial launch activities for ONS-5010.
Key Takeaways
Outlook Therapeutics reported its fiscal second quarter results, highlighting the submission of the BLA for ONS-5010 and ongoing pre-commercial launch activities. The company reported a net loss of $19.7 million, or $0.09 per share, and had cash and cash equivalents of $58.4 million as of March 31, 2022.
Submitted BLA for ONS-5010.
Ramping up pre-commercial launch activities.
Building commercial team and engaging with partners and payors.
Expects to submit registration documents in Europe in Q4 2022.
Outlook Therapeutics
Outlook Therapeutics
Forward Guidance
Outlook Therapeutics is focused on obtaining FDA approval for ONS-5010, planning for commercial launch, and exploring strategic partnerships. The company believes it is in a strong financial position and is taking steps to extend the maturity of its unsecured notes.
Positive Outlook
- Potential FDA approval of ONS-5010 in early 2023
- Plans to submit a supplementary application (sBLA) for approval to provide the product in a pre-filled, silicone oil-liquid free syringe
- Building best-in-class partnerships with FUJIFILM Diosynth Biotechnologies and Aji Biopharma Services
- Exploring potential strategic commercialization partners
- Plans to continue using ATM program for capital
Challenges Ahead
- Uncertainty of future impacts related to the ongoing COVID-19 pandemic
- Risks associated with developing pharmaceutical product candidates
- Risks of conducting clinical trials
- Risks in obtaining necessary regulatory approvals
- Cash and cash equivalents on hand are expected to provide funding into the first calendar quarter of 2023.