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Dec 31, 2024
Omeros Q4 2024 Earnings Report
Omeros Corporation reported its financial results for the fourth quarter and full year ended December 31, 2024.
Key Takeaways
Omeros Corporation reported a net loss of $31.4 million for the fourth quarter of 2024, an improvement from the $32.2 million net loss in the previous quarter. The company's cash and short-term investments decreased significantly from the prior year, reflecting substantial cost outlays. Key developments include the resubmission of the BLA for narsoplimab and the initiation of a Phase 3 program for zaltenibart.
Net loss for Q4 2024 was $31.4 million, or $0.54 per share, an improvement from Q3 2024.
Cash and short-term investments decreased by $81.7 million from December 31, 2023, totaling $90.1 million.
OMIDRIA royalties for Q4 2024 were $10.1 million on U.S. net sales of $33.6 million.
The Biologics License Application (BLA) for narsoplimab in TA-TMA was resubmitted to the FDA, with a target PDUFA date in September 2025.
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CapyFin.com Forward Guidance
Omeros anticipates continued progress in its clinical programs, including regulatory approvals and ongoing trials, with a focus on expanding partnerships and generating shareholder value.
Positive Outlook
- Narsoplimab BLA resubmitted to FDA with a PDUFA date in September 2025, indicating potential approval.
- MAA for narsoplimab in TA-TMA expected to be submitted in Europe in the first half of 2025.
- Phase 3 program for zaltenibart in PNH is underway, with data readout expected late next year.
- NIDA-funded OMS527 trial in cocaine use disorder patients expected to have data readout by year-end 2025.
- Ongoing efforts to establish ex-U.S. partnerships for zaltenibart and narsoplimab.
Challenges Ahead
- Actual results could differ materially due to unfavorable or unexpected interpretation of statistical analyses.
- Potential differences between diagnostic criteria in pivotal trial and external registry could impact regulatory outcomes.
- Unanticipated or unexpected outcomes of regulatory processes in relevant jurisdictions.
- Challenges associated with manufacture or supply of products to support clinical trials and commercial sale.
- Changes in reimbursement and payment policies by government and commercial payers could affect commercial success.