Omeros(US:OMER)2025-11-13 21:11Financial Performance - The net loss for the nine months ended September 30, 2025, was $89,801,000, compared to a net loss of $125,457,000 for the same period in 2024, representing a 28.5% improvement[19] - The company reported a basic net loss per share of $0.47 for the three months ended September 30, 2025, compared to $0.56 for the same period in 2024, reflecting a 16.1% improvement[19] - For the nine months ended September 30, 2025, the net loss was $89.8 million, an improvement from a net loss of $125.5 million in the same period of 2024, representing a 28.5% reduction[24] - The company recorded a net loss from discontinued operations of $9.674 million for the three months ended September 30, 2025[130] Assets and Liabilities - Total current assets decreased from $134,120,000 in December 2024 to $71,805,000 in September 2025, a decline of approximately 46.5%[16] - The total liabilities increased from $277,079,000 in December 2024 to $185,706,000 in September 2025, indicating a reduction in the company's debt obligations[16] - The total shareholders' deficit increased from $182,609,000 in December 2024 to $220,478,000 in September 2025, indicating a worsening financial position[16] - Cash and cash equivalents decreased from $3,400,000 in December 2024 to $2,395,000 in September 2025, a decline of approximately 29.5%[16] - The company had cash, cash equivalents, and short-term investments of $36.1 million as of September 30, 2025[40] Expenses - Research and development expenses for the three months ended September 30, 2025, were $15,995,000, down 33.8% from $24,084,000 in the same period of 2024[19] - Selling, general and administrative expenses for the three months ended September 30, 2025, were $10,397,000, a decrease of 8.2% from $11,323,000 in the same period of 2024[19] - Total stock-based compensation for the nine months ended September 30, 2025, was $6.5 million, down from $8.1 million in the same period of 2024[150] - Selling, general and administrative expenses for the nine months ended September 30, 2025, were $31.865 million, down from $37.395 million in the prior year, primarily due to reduced employee compensation expenses[205] Debt and Financing - The company has an ATM equity offering facility allowing for proceeds of up to $150.0 million, with net proceeds of $9.0 million and $15.3 million received during the three and nine months ended September 30, 2025, respectively[46] - The company reduced the aggregate principal balance of its 2026 Notes from $97.9 million to $17.1 million through a Convertible Note Exchange and an Equitization Transaction[56] - The company has an outstanding Term Loan of $67.1 million, secured by a first-priority security interest in its tangible and intangible property[105] - The anticipated transaction with Novo Nordisk is expected to provide $240.0 million in upfront cash, which will be used to repay the Term Loan[108] - The company recorded a premium of $29.3 million related to the repurchase of 2026 Notes, which is amortized as a reduction of term debt and interest expense[53] Clinical Development and Regulatory - The BLA for narsoplimab in TA-TMA was resubmitted to the FDA in March 2025, with a target action date extended to December 26, 2025[34] - The company has completed two Phase 2 clinical trials for zaltenibart in paroxysmal nocturnal hemoglobinuria (PNH) and is transitioning ongoing programs to Novo Nordisk[30][31] - The company is developing zaltenibart for PNH and C3G, with two Phase 2 trials substantially completed[164] - The company submitted a Marketing Authorization Application for narsoplimab in the EU, expecting an opinion by mid-2026[159] Cash Flow and Operations - Cash used in operating activities for the nine months ended September 30, 2025, was $76.3 million, down from $119.8 million in the prior year[24] - The company maintained a balance of unrestricted cash above $25.0 million, complying with debt covenants throughout the reporting period[41] - The company is unable to estimate long-term costs for the continued development of product candidates due to the unpredictable nature of clinical development activities[203] Future Expectations - The company expects to repay all outstanding obligations related to the Term Loan upon closure of the transaction with Novo Nordisk, anticipated in Q4 2025[128] - The company anticipates that research and development expenses in the fourth quarter of 2025 will be comparable to those in the third quarter[201] - The company expects selling, general and administrative expenses in the fourth quarter of 2025 to be higher than in the third quarter, mainly due to increased marketing expenses for the anticipated launch of narsoplimab[207] - The company expects interest expense for the fourth quarter of 2025 to be higher compared to the third quarter, assuming no remeasurement adjustment to the OMIDRIA contract royalty obligation[213]