• Net Loss: $32.2 million or 56 per share for Q3 2024, compared to $56 million or 97 per share in Q2 2024.
• Cash and Investments: $123.2 million as of September 30, 2024, a decrease of $35.8 million from June 30, 2024.
• Costs and Expenses: $35.4 million for Q3 2024, a decrease of $23.8 million from Q2 2024.
• Interest Expense: $4.1 million for Q3 2024, $5.2 million lower than Q2 2024.
• Interest and Other Income: $2.3 million for Q3 2024.
• Income from Discontinued Operations: $4.9 million for Q3 2024.
• Omidria Royalties: $9.3 million for Q3 2024 on net sales of $31 million, compared to $10.9 million on net sales of $36.4 million in Q2 2024.

• Warning! GuruFocus has detected 2 Warning Signs with OMER.

Release Date: November 13, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Omeros Corp (NASDAQ:OMER) reported a significant reduction in net loss for Q3 2024, decreasing from $56 million in Q2 to $32.2 million.
• The company has $123.2 million in cash and investments as of September 30, 2024, providing a solid financial base.
• Omeros Corp (NASDAQ:OMER) is making progress with the FDA on the resubmission of its Biologics License Application for narsoplimab, with expectations for commercial sales in 2025.
• The company has initiated Phase 3 clinical programs for its MASP-3 inhibitor, Zoltan Aart, targeting rare diseases such as PNH and C3G.
• Omeros Corp (NASDAQ:OMER) received a rare pediatric disease designation from the FDA for Zoltan Aart in treating C3G, which could lead to a valuable priority review voucher.

Negative Points

• Omeros Corp (NASDAQ:OMER) experienced a decrease in cash and investments by $35.8 million from June 30, 2024.
• The company is still awaiting FDA feedback on its statistical analysis plan for narsoplimab, which could delay the resubmission process.
• Omeros Corp (NASDAQ:OMER) faces competition in the market for alternative pathway therapeutics, which could impact its market share.
• The company's royalty income from Omidria decreased in Q3 2024 compared to the previous quarter and the same quarter last year.
• Omeros Corp (NASDAQ:OMER) anticipates similar operating costs in Q4 2024, indicating ongoing financial pressure.

Q & A Highlights

Q: Given the brevity of the FDA's requests for narsoplimab, is it reasonable to expect commercial sales in 2025? A: Gregory Demopulos, CEO: Yes, we are targeting 2025 for commercial sales. We plan to quickly resubmit the BLA once we receive and align on the FDA's comments regarding the sensitivity analyses.

Q: Can you provide more details on the phase three trial designs for the MASP-3 inhibitor, particularly for PNH? A: Gregory Demopulos, CEO: The phase three trials will include a switch-over trial for patients not optimally responding to C5 inhibitors and a trial for patients not previously treated with complement inhibitors. Both trials have received positive feedback from FDA and European regulators.

Q: What is your strategy regarding the potential priority review voucher for pediatric C3G? A: Gregory Demopulos, CEO: It's premature to discuss our strategy. We will assess the landscape and decide whether to sell or retain the voucher based on our program's progress and market conditions.

Q: Can you provide an estimate of the size and cost of the OMS 906 phase three program, and will you need a partner to complete it? A: Gregory Demopulos, CEO: We plan to move forward independently, confident in our data and safety profile. The studies will be relatively small, with each trial involving slightly below 100 patients, making them manageable with our current resources.

Q: How will the enrollment process for the OMS 906 trials be managed to ensure timely completion? A: Gregory Demopulos, CEO: We have identified patient pockets and expect to enroll quickly. Our clinical operations team has done significant groundwork to line up patients, which should positively affect the trial's fixed monthly costs.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.