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Omeros(OMER) - 2024 Q4 - Annual Results
OMEROmeros(OMER)2025-03-31 20:25

Financial Performance - Net loss for Q4 2024 was 31.4million,or31.4 million, or 0.54 per share, compared to a net loss of 32.2million,or32.2 million, or 0.56 per share in Q3 2024[3]. - For the year ended December 31, 2024, net loss was 156.8million,or156.8 million, or 2.70 per share, compared to a net loss of 117.8million,or117.8 million, or 1.88 per share in the prior year[8]. - The company reported a net loss of 31.4millionforQ42024,comparedtoanetlossof31.4 million for Q4 2024, compared to a net loss of 9.1 million in Q4 2023[21]. - The accumulated deficit increased to 910.3millionasofDecember31,2024,from910.3 million as of December 31, 2024, from 753.5 million a year earlier[23]. Cash and Investments - Cash and short-term investments available for operations and debt servicing as of December 31, 2024, were 90.1million,adecreaseof90.1 million, a decrease of 81.7 million from December 31, 2023[9]. - Cash and cash equivalents were 3.4millionasofDecember31,2024,comparedto3.4 million as of December 31, 2024, compared to 7.1 million at the end of 2023[23]. Revenue and Royalties - OMIDRIA royalties earned in Q4 2024 were 10.1milliononU.S.netsalesof10.1 million on U.S. net sales of 33.6 million, compared to 9.3milliononU.S.netsalesof9.3 million on U.S. net sales of 31.0 million in Q3 2024[10]. - Net income from discontinued operations was 5.2millionforQ42024,comparedto5.2 million for Q4 2024, compared to 4.9 million in Q3 2024[12]. Operating Expenses - Total operating expenses for Q4 2024 were 35.7million,slightlyupfrom35.7 million, slightly up from 35.4 million in Q3 2024[11]. - Significant cost outlays during 2024 totaled 42.7million,including42.7 million, including 21.7 million for repurchasing convertible senior notes and 19.1millionfornarsoplimabdrugsubstancedelivery[9].ResearchanddevelopmentexpensesforQ42024were19.1 million for narsoplimab drug substance delivery[9]. - Research and development expenses for Q4 2024 were 23.3 million, down from 28.9millioninQ42023[21].Selling,generalandadministrativeexpensesincreasedto28.9 million in Q4 2023[21]. - Selling, general and administrative expenses increased to 12.3 million in Q4 2024 from 10.9millioninQ42023[21].Interestexpensedecreasedto10.9 million in Q4 2023[21]. - Interest expense decreased to 3.2 million in Q4 2024 from 4.1millioninthepriorquarter,primarilyduetotheremeasurementoftheOMIDRIAroyaltyobligation[11].DrugDevelopmentandRegulatoryUpdatesThebiologicslicenseapplication(BLA)fornarsoplimabwasresubmittedtotheFDAinMarch2025,withatargetactiondateofSeptember2025[4].TheEuropeanmarketingauthorizationapplication(MAA)fornarsoplimabisexpectedtobesubmittedinthefirsthalfof2025[3].ThePhase3programforzaltenibartintreatingparoxysmalnocturnalhemoglobinuria(PNH)hasbeeninitiated,includingtwostudiestargetingdifferentpatientpopulations[5].NIDAconfirmedfundingof4.1 million in the prior quarter, primarily due to the remeasurement of the OMIDRIA royalty obligation[11]. Drug Development and Regulatory Updates - The biologics license application (BLA) for narsoplimab was resubmitted to the FDA in March 2025, with a target action date of September 2025[4]. - The European marketing authorization application (MAA) for narsoplimab is expected to be submitted in the first half of 2025[3]. - The Phase 3 program for zaltenibart in treating paroxysmal nocturnal hemoglobinuria (PNH) has been initiated, including two studies targeting different patient populations[5]. - NIDA confirmed funding of 4.02 million for the OMS527 program, aimed at treating cocaine use disorder, starting April 1, 2025[6]. - Narsoplimab demonstrated a hazard ratio of 0.32 in overall survival compared to an external control population of TA-TMA patients, indicating significant clinical efficacy[4]. - Omeros' lead drug candidate, narsoplimab, is pending FDA review for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy[16]. Assets - Total assets decreased to 277.1millionasofDecember31,2024,downfrom277.1 million as of December 31, 2024, down from 378.3 million a year earlier[23].