Omeros(OMER) - 2024 Q3 - Quarterly Report

Financial Performance - Net loss from continuing operations for the three months ended September 30, 2024, was $37.1 million, compared to a loss of$51.7 million for the same period in 2023, representing a 28.2% improvement [12]. - The company reported a net loss of $32.2 million for the three months ended September 30, 2024, compared to a net loss of$37.8 million for the same period in 2023, reflecting a 14.6% decrease [12]. - Total costs and expenses for the nine months ended September 30, 2024, were $133.6 million, an increase of 7.1$124.8 million for the same period in 2023 [12]. - Cash used in operations for the nine months ended September 30, 2024 was $119.8 million, which includes an$18.4 million charge for delivery of narsoplimab drug substance [163]. - The company reported a net loss of $32.2 million and$125.5 million for the three and nine months ended September 30, 2024, respectively [163]. Cash and Investments - Cash and cash equivalents at the end of the period were $1.5 million, down from$30.6 million at the end of September 2023 [17]. - The company has $123.2 million in cash, cash equivalents, and short-term investments as of September 30, 2024, with cash used in operations amounting to$119.8 million for the nine months ended September 30, 2024 [32]. - Total short-term investments amounted to $121.640 million as of September 30, 2024, with U.S. government securities and money-market funds comprising the majority [56]. - As of September 30, 2024, the company had cash, cash equivalents, and short-term investments of$123.2 million available to fund operations and service debt [146]. Research and Development - Research and development expenses for the three months ended September 30, 2024, were $24.1 million, down 24.1$31.7 million in the same period of 2023 [12]. - The company is focused on developing first-in-class therapeutics targeting immunologic disorders, cancers, and addictive disorders [19]. - The company is developing narsoplimab (OMS721) for TA-TMA, having completed a pivotal clinical trial and submitted a BLA to the FDA [117]. - Narsoplimab shows potential as a therapeutic for COVID-19 and ARDS, supported by in vivo animal data and proof-of-concept clinical data [118]. - OMS1029, a long-acting antibody targeting MASP-2, has completed Phase 1 trials, confirming once-quarterly low-volume dosing with no safety concerns [119]. - Zaltenibart, targeting MASP-3, is advancing to Phase 3 trials for PNH and C3G, with multiple ongoing Phase 2 trials [120][121]. - The Phase 2 trial for zaltenibart in patients unsatisfied with ravulizumab showed significant improvements in hemoglobin levels and reticulocyte counts [124]. Debt and Financing - The company entered into a Credit Agreement providing for a senior secured term loan facility of up to $92.1 million, with an initial term loan of$67.1 million [29]. - The company repurchased $118.1 million of its existing 5.25$51.0 million reduction in outstanding debt [30]. - The Initial Term Loan amount outstanding was $67,077,000 as of September 30, 2024, with a total long-term debt of$92,427,000 [67]. - The company accrued $0.6 million in additional cash consideration to a certain Lender as a post-closing adjustment under the 2026 Note Repurchase Transaction [66]. - The company has a sales agreement to sell shares of common stock for up to$150.0 million to raise additional capital [34]. Discontinued Operations - The company has classified the results of OMIDRIA activities as discontinued operations following its sale to Rayner Surgical Inc. [26]. - The company recognized net income from discontinued operations of $4.881 million for the three months ended September 30, 2024, compared to$13.906 million for the same period in 2023, a decrease of approximately 65% [90]. - Cash provided by discontinued operations from operating activities was $30.619 million for the nine months ended September 30, 2024, significantly lower than$232.081 million for the same period in 2023 [92]. Stock and Compensation - Stock-based compensation expense for the nine months ended September 30, 2024, was $8.1 million, compared to$9.0 million for the same period in 2023 [17]. - The total estimated compensation expense yet to be recognized on outstanding options is $14.4 million [111]. - The share repurchase program authorized up to$50 million, with 5 million shares repurchased at an average price of $3.30 per share [105]. - As of September 30, 2024, there were 18.13 million stock options outstanding, with a weighted average exercise price of$8.41 per share [110]. Future Outlook - The company plans to resubmit the BLA for narsoplimab following FDA feedback expected in November 2024 [117]. - The company expects research and development expenses in Q4 2024 to be similar to those in Q3 2024 [151]. - The company anticipates that selling, general and administrative expenses in Q4 2024 will be similar to those in Q3 2024 [154]. - The company expects to initiate Phase 3 trials for C3G in the first half of 2025, following ongoing Phase 2 trials [127].