Release Date: March 31, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Omeros Corp (OMER, Financial) has resubmitted its Biologics License Application (BLA) for narsoplimab in the treatment of TA-TMA, with a PDUFA date set for September, indicating progress towards potential approval.
- The company has over $90 million in cash and investments, providing a financial cushion to support ongoing operations and development programs.
- Omeros Corp (OMER) is actively pursuing partnerships and other financial strategies, such as royalty monetization and equity transactions, to strengthen its financial position.
- The company has a robust pipeline, including the development of zaltenibart for PNH, which is in Phase 3 trials, and OMS1029, a next-generation MASP-2 inhibitor.
- Omeros Corp (OMER) has established strong relationships with key transplant centers in the US, positioning it well for the potential launch of narsoplimab.
Negative Points
- Omeros Corp (OMER) reported a significant net loss of $156.8 million for the full year 2024, highlighting ongoing financial challenges.
- The company is in preliminary discussions to restructure its 2026 convertible notes, indicating potential financial strain and the need for debt management.
- There is uncertainty regarding the pricing strategy for narsoplimab, which could impact market acceptance and revenue generation.
- The company faces competition in the complement inhibitor space, which could affect the market share and success of its products.
- Omeros Corp (OMER) has not yet disclosed specific plans for ex-US commercialization of its products, which could limit its global market reach.
Q & A Highlights
Q: Can you explain why you believe the resubmission of the BLA for narsoplimab is strong and what the implications are?
A: Gregory Demopulos, CEO, explained that the statistical analysis plan was created with FDA's agreement, and the results are impressively strong across all analyses. The primary analysis showed a more than threefold improvement in survival with a P value of less than 0.00001, indicating statistically significant and clinically meaningful results. Catherine Melfi, Chief Regulatory Officer, added that the package is solid due to a well-matched external control group and strong results.
Q: How are you thinking about pricing for narsoplimab now that you are in launch preparation mode?
A: Gregory Demopulos, CEO, stated that while pricing plans have not been disclosed, it is expected to be similar to other complement inhibitors used in TA-TMA. Nadia Dac, Chief Commercial Officer, added that narsoplimab's significant value and potential administration in both inpatient and outpatient settings are being considered in pricing determination.
Q: What is the strategy for funding given the commercial launch and multiple Phase 3 trials?
A: Gregory Demopulos, CEO, mentioned ongoing discussions to restructure convertible notes and bring in additional capital. Options include partnering, debt instruments, royalty monetization, or equity. The company is confident in managing the balance sheet effectively.
Q: Where does the company stand on manufacturing scalability for narsoplimab, and how are you increasing awareness among treating physicians?
A: Gregory Demopulos, CEO, confirmed that they have sufficient drug supply to support narsoplimab for the first several years. Nadia Dac, Chief Commercial Officer, highlighted efforts to build awareness of TA-TMA among top transplant centers and physicians, emphasizing the need for a solution.
Q: How does Omeros view its strategic direction in terms of commercialization and partnerships?
A: Gregory Demopulos, CEO, stated that Omeros plans to launch narsoplimab independently in the US but expects to partner for ex-US commercialization. The company aims to manage ex-US commercialization independently in the future and is focused on partnering programs regionally or internationally.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
