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Jun 30
Omeros Q2 2025 Earnings Report
Omeros reported a reduced net loss in Q2 2025, driven by lower manufacturing expenses and strategic financial maneuvers.
Key Takeaways
Omeros Corporation significantly improved its financial position in the second quarter of 2025, reducing its net loss to $25.4 million from $56.0 million in the prior year, primarily due to decreased narsoplimab drug substance manufacturing expenses. The company also strengthened its balance sheet by reducing near-term debt and securing new capital, while advancing its key clinical programs, particularly narsoplimab for TA-TMA with an extended PDUFA date.
Net loss significantly decreased to $25.4 million ($0.43 per share) in Q2 2025, compared to $56.0 million ($0.97 per share) in Q2 2024.
The company reduced its near-term debt by over $100 million through convertible senior note exchanges and received $20.6 million in new capital from an equity financing.
The Biologics License Application (BLA) for narsoplimab in TA-TMA has an extended PDUFA date of December 26, 2025, with ongoing positive interactions with the FDA.
Omeros is actively preparing for the commercial launch of narsoplimab, engaging with hospital formulary decision-makers and payers, and submitting manuscripts detailing its safety and survival benefits.
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CapyFin.com Forward Guidance
Omeros anticipates significant milestones in late 2025 and into 2026, including potential FDA approval for narsoplimab, advancement of its PDE7 inhibitor program, and progress in its oncology platform, supported by ongoing partnering discussions for its clinical assets.
Positive Outlook
- Anticipated FDA approval and subsequent launch of narsoplimab for TA-TMA by December 26, 2025.
- NIDA's continued funding for the PDE7 inhibitor program (OMS527) for cocaine use disorder, with clinical studies targeted for early 2026.
- OncotoX-AML program on track to enter the clinic within 18-24 months, showing promising efficacy over current AML standard of care.
- Substantial industry interest and advancing partnering discussions for various clinical assets, with potential multi-billion dollar total transaction value for one agreement.
- Potential upfront cash payment from a transaction expected to fully repay term loan, remaining 2026 Notes, and provide over 12 months of post-closing operations capital.
Challenges Ahead
- The PDUFA date for narsoplimab has been extended to December 26, 2025, from an initial September 25, 2025.
- FDA has requested additional preclinical information for OMS527 before initiating the clinical in-patient study in cocaine users.
- The scope of IND-enabling work for the OncotoX biologics program has been limited to preserve available capital.
- The Company can provide no assurance that any asset acquisition and/or licensing transaction will be consummated on favorable terms or at all.
- Lead MASP-3 inhibitor zaltenibart and long-acting MASP-2 inhibitor OMS1029 are currently paused to prioritize narsoplimab.