OMEROS CORP Q4 FY2024 earnings call

Gregory Demopulos began by providing an overview of 2024 financial results and development programs. The company is focused on restructuring its balance sheet, having reduced the 2026 convertible notes and in preliminary discussions to retire/refinance remaining notes. Discussions are ongoing regarding potential partnerships, royalty monetization, and other financing options. On development programs: Narsoplimab's BLA was resubmitted for TA-TMA, showing significant survival benefit with robust statistical analyses. Zaltenibart is in Phase 3 for PNH with positive trial data, including strong efficacy and no safety concerns. OMS527 is in a Phase 1b trial for cocaine use disorder, with NIDA funding. The company also has ongoing programs in oncology and other pipelines. OMIDRIA royalties for Q4 2024 were $10.1 million on net sales of $33.6 million.

For the fourth quarter of 2024, Omeros reported a net loss of $31.4 million, or $0.54 per share, compared to a net loss of $32.2 million, or $0.56 per share in the third quarter. The full year 2024 net loss was $156.8 million, or $2.70 per share. As of December 31, 2024, the company had over $90 million in cash and investments. OMIDRIA royalties for the fourth quarter of 2024 totaled $10.1 million based on OMIDRIA net sales of $33.6 million, which compared to $9.3 million in royalties on $31 million net sales in the third quarter.

The company is in preliminary discussions to restructure the 2026 convertible notes. Anticipates progress on the BLA and MAA submissions for narsoplimab. Zaltenibart's Phase 3 trials are expected to yield data by the fourth quarter of 2025. Plans are in place for the market launch of narsoplimab and Zaltenibart, with the commercial team already planning for their respective launches.

Regulatory uncertainties surrounding the approval of BLA and MAA submissions. Market competition in the complement inhibitor space. Potential challenges in successfully restructuring debt and finalizing partnerships.

Q: Steve Brozak asked about the strength of the BLA submission and its implications.

A: Gregory Demopulos and Cathy Melfi explained that the submission was based on FDA-agreed protocols, with strong statistical analyses showing a more than three-fold improvement in survival for narsoplimab, and the data were impressively consistent across various analyses.

Q: Olivia Brayer inquired about pricing for narsoplimab and liver toxicity in Zaltenibart.

A: Nadia Dac discussed that pricing for narsoplimab is being considered with an eye on its value proposition, and Steven Whitaker stated that no safety signal of concern for liver toxicity has been observed with Zaltenibart.

Q: John Gionco asked about manufacturing scalability for narsoplimab and awareness.

A: Gregory Demopulos and Nadia Dac mentioned that there is sufficient manufacturing supply to support market demand and that the company is actively working to increase awareness among treating physicians through pre-launch efforts.

Q: Brandon Folkes asked about strategic long-term plans and partnering.

A: Gregory Demopulos stated that the company plans to launch narsoplimab independently in the U.S. and partner Zaltenibart ex-U.S., with a focus on leveraging the pipeline for future growth.