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Dec 31, 2020
Omeros Q4 2020 Earnings Report
Reported financial results for the fourth quarter and year ended December 31, 2020.
Key Takeaways
Omeros Corporation reported fourth-quarter revenues of $10.6 million, primarily from OMIDRIA sales, and a net loss of $37.3 million, or $0.60 per share. The company's cash, cash equivalents, and short-term investments available for operations totaled $135.0 million as of December 31, 2020.
Revenues for Q4 2020 were $10.6 million, a decrease from $26.1 million in Q3 2020, mainly due to the expiration of pass-through reimbursement for OMIDRIA.
CMS confirmed OMIDRIA qualifies for separate payment in the ASC setting, effective retroactively as of October 1, 2020.
The BLA for narsoplimab was accepted and granted priority review by the FDA, with a PDUFA date of July 17, 2021.
Narsoplimab entered the I-SPY COVID-19 platform trial as the only complement inhibitor.
Forward Guidance
Omeros anticipates continued progress in 2021, with plans to launch narsoplimab upon approval, advance clinical trials for narsoplimab and OMS906, and leverage OMIDRIA revenues to fund the pipeline.
Positive Outlook
- Commercial launch plan for narsoplimab is on track pending approval.
- OMIDRIA revenues are increasing and will continue to provide working capital.
- OMS906 is on schedule to read out initial data next quarter.
- Narsoplimab is the focus of growing attention from international government agencies.
- Priority review granted to the BLA for narsoplimab
Challenges Ahead
- Uncertainties related to regulatory processes and oversight.
- Risks associated with product commercialization and commercial operations.
- Potential changes in reimbursement and payment policies.
- Unproven preclinical and clinical development activities.
Historical Earnings Impact
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Avg. Return Before/After Earnings
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