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Sep 30, 2021
Omeros Q3 2021 Earnings Report
Reported an increase in OMIDRIA revenues and a net loss for the third quarter of 2021.
Key Takeaways
Omeros Corporation reported a net loss of $22.7 million, or $0.36 per share, for the third quarter of 2021. OMIDRIA revenues for the third quarter of 2021 were $30.0 million, a 4.1 percent increase compared to the second quarter.
OMIDRIA revenues for Q3 2021 were $30.0 million, a 4.1% increase over the prior quarter.
Net loss in Q3 2021 was $22.7 million, or $0.36 per share.
Omeros had cash, cash equivalents and short-term investments of $50.4 million as of September 30, 2021.
CMS reconfirmed that OMIDRIA qualifies for separate payment in the ASC setting.
Omeros
Omeros
Forward Guidance
Omeros expects its portfolio of commercial and development programs to continue to advance throughout 2022.
Positive Outlook
- CMS reconfirming separate payment for OMIDRIA in the ASC setting.
- Increasing percentage of Medicare Advantage and commercial payers also recognizing the benefits of the drug and appropriately reimbursing for its use.
- Focus resources on complement programs, primarily to achieve FDA approval of the narsoplimab BLA in HSCT-TMA.
- Drive the other high-priority components of complement franchise – the Phase 3 trial of narsoplimab in IgA nephropathy and our MASP-3 inhibitor OMS906.
- Expect to accelerate OMS906 from a Phase 1 trial in healthy subjects to assessing the drug in PNH patients.
Challenges Ahead
- Receipt of a Complete Response Letter from the U.S. FDA regarding the Company’s biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
- Will require a Type A meeting with FDA to determine the most expeditious path forward for approval of narsoplimab in the treatment of HSCT-TMA.
- Risks associated with product commercialization and commercial operations.
- Unproven preclinical and clinical development activities.
- Impact of COVID-19 on our business, financial condition and results of operations.