Omeros(US:OMER)2022-05-11 02:26Financial Data and Key Metrics Changes - The company reported a net loss of $33 million or $0.53 per share for Q1 2022, compared to a loss of $35.1 million or $0.57 per share in the same quarter of the previous year [32][57] - Non-cash expenses were $4.2 million or $0.07 per share, consistent with the prior year [32][57] - Cash and investments decreased by $15 million from the previous year-end, totaling $142.2 million as of March 31, 2022 [36][58] Business Line Data and Key Metrics Changes - The OMIDRIA product line was divested to Rayner Surgical, leading to a reclassification of historical revenues and expenses into discontinued operations [31][54] - OMIDRIA net sales reported by Rayner for Q1 2022 were $27.8 million, representing a 31% increase from $21.1 million in Q1 2021 [33][34] - The company earned $13.8 million in royalties from OMIDRIA sales, reflecting a 50% royalty rate on net sales [34][61] Market Data and Key Metrics Changes - The first quarter is typically the lowest for cataract procedure volume, historically resulting in weaker OMIDRIA sales, but growth is expected to continue [35] - The company has $16.3 million in receivables primarily related to OMIDRIA royalties, expected to be collected shortly [36][58] Company Strategy and Development Direction - The company is focused on advancing its MASP-2 and MASP-3 programs, with ongoing trials for narsoplimab in various indications [22][42] - The company is pursuing a dispute resolution process with the FDA regarding narsoplimab, aiming for regular approval based on existing data [11][14] - The company is also exploring life cycle management for its MASP-2 program with OMS1029, a long-acting second-generation antibody [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of their data and the likelihood of a favorable outcome from the FDA dispute resolution process [14][90] - The company anticipates near-term value-driving milestones throughout 2022 and is committed to advancing its pipeline [100] Other Important Information - The company has a $150 million at-the-market sales agreement that has not yet been utilized [36] - The enactment of the NOPAIN Act could provide a $200 million milestone if separate payment for OMIDRIA is secured for a continuous period of four years [38][39] Q&A Session Summary Question: What is the optimal outcome from the dispute process regarding narsoplimab? - The company is requesting regular approval based on existing data, with the optimal outcome being agreement with their position leading to label discussions [70][72] Question: What critiques were repeated by the FDA after the Type A meeting? - The company addressed specific critiques regarding the interpretation of treatment response, which they believed had been adequately resolved [85][86] Question: What happens if the company does not prevail in the dispute resolution? - The company has considered alternative scenarios but remains confident in the strength of their data and the likelihood of a successful outcome [94][96]