Omeros(US:OMER)2021-05-11 02:03Financial Data and Key Metrics Changes - Net revenues from the sale of OMIDRIA in Q1 2021 were $21.1 million, doubling from the previous quarter [25] - The net loss for Q1 2021 was $35.1 million or $0.57 per share, including noncash charges of $4.1 million or $0.07 per share [27][47] - As of March 31, 2021, the company had $100.5 million in cash, cash equivalents, and short-term investments [27][49] Business Line Data and Key Metrics Changes - OMIDRIA sales have shown significant growth, with a 43% increase in the number of ASCs ordering compared to Q4 2020, leading to a total ASC purchase volume increase of 274% [36] - Narsoplimab is expected to be the first drug approved specifically for the treatment of TA-TMA, with a PDUFA date set for July 17, 2021 [7][10] Market Data and Key Metrics Changes - The approval of new ICD-10 diagnosis and procedural codes for TA-TMA and the administration of narsoplimab is expected to enhance reimbursement tracking and facilitate the drug's market entry [8][11][88] - The company is expanding its Phase III ARTEMIS-IGAN trial for narsoplimab to additional geographies, including China, where IgA nephropathy is more prevalent [23] Company Strategy and Development Direction - The company is focused on the launch readiness of narsoplimab and building a strong commercial team to support its market entry [31] - The company is also advancing its second-generation long-acting MASP-2 antibody, OMS1029, and small molecule MASP-2 inhibitors for oral administration [41][42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of OMIDRIA revenues as ASC customers ramp up their usage following the restoration of separate payment [52] - The management believes that COVID-19 will remain a significant issue globally for years to come, emphasizing the need for effective therapeutics like narsoplimab [75] Other Important Information - The NOPAIN Act, which mandates separate payment for non-opioid surgical pain management drugs like OMIDRIA, has strong bipartisan support and is expected to enhance market access [28][116] - The company is actively engaging with key transplant societies and organizations to support the launch of narsoplimab [12] Q&A Session Summary Question: Feedback on OMIDRIA sales - Management expressed satisfaction with the sales numbers, especially considering the reimbursement uncertainty earlier in the quarter [57][59] Question: View on Novartis' LNP023 data in IgA nephropathy - Management highlighted that narsoplimab shows significantly higher efficacy in reducing proteinuria compared to Novartis' data [65][66] Question: Impact of COVID-19 on narsoplimab's commercial potential - Management indicated that while vaccines are important, the need for therapeutics like narsoplimab remains critical due to ongoing COVID-19 challenges [75][76] Question: Awareness of TA-TMA and potential for consensus building - Management noted that awareness of TA-TMA is growing, and the introduction of dedicated diagnostic codes will facilitate better tracking and treatment [80][81] Question: Impact of ICD codes on utilization - Management expects the new ICD codes to positively influence utilization starting October 1, 2021, enhancing the launch momentum for narsoplimab [87][89] Question: Timeline for data from the I-SPY study - Management stated that they are not directly involved in the I-SPY study and cannot provide a specific timeline for data release [92] Question: Enrollment pace in the IgA nephropathy study - Management confirmed that enrollment is picking up again, especially with plans to expand into China [97][100]