Loading...
•
Jun 30, 2023
Outlook Therapeutics Q3 2023 Earnings Report
Reported financial results for the third quarter of fiscal year 2023 and reiterated key anticipated near-term milestones.
Key Takeaways
Outlook Therapeutics reported a net loss attributable to common stockholders of $20.7 million for the fiscal third quarter ended June 30, 2023. The company's cash and cash equivalents were $33.7 million as of June 30, 2023, expected to fund operations through the anticipated approval of the BLA for ONS-5010.
Submitted a PHSA 351(a) BLA for ONS-5010 as an original biologic application.
ONS-5010 consistently improved BCVA by ≥ 15 letters from baseline to 11 months (41.7% compared to 23.1% in LUCENTIS group, p = 0.0052) in the NORSE TWO Phase 3 clinical trial.
Pre-launch preparations for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) are proceeding as planned, including commercial inventory production and a strategic distribution partnership with AmerisourceBergen.
Submitted a Marketing Authorization Application (MAA) in Europe, which was validated for review in December 2022.
Outlook Therapeutics
Outlook Therapeutics
Forward Guidance
Outlook Therapeutics anticipates potential FDA approval of the BLA for ONS-5010 in the third calendar quarter of 2023, and potentially through the fourth calendar quarter of 2023.
Positive Outlook
- Potential FDA approval of ONS-5010 in the third calendar quarter of 2023.
- Ongoing commercial planning to support potential approval of ONS-5010.
- Strategic distribution partnership with AmerisourceBergen to increase market access.
- Collaborative discussions with payors and the retina community to bring ONS-5010 to market.
- Formal review process of the MAA by the EMA's Committee for Medicinal Products for Human Use (CHMP) is underway with an estimated decision date expected in the first half of 2024.
Challenges Ahead
- Uncertainty of future impacts related to macroeconomic factors, including as a result of the ongoing conflict between Russia and Ukraine.
- High interest rates.
- Inflation.
- Potential future bank failures on the global business environment.
- Risks associated with developing pharmaceutical product candidates and obtaining necessary regulatory approvals.