Omeros(OMER) - 2020 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Omeros reported a net loss of $37.3 million for Q4 2020, equating to $0.60 per share, with non-cash charges of $3.5 million or $0.06 per share [32][43] - Total revenues for Q4 2020 were $10.6 million, significantly impacted by uncertainty around OMIDRIA reimbursement [30][43] - Cash, cash equivalents, and short-term investments available for operations were $135 million as of December 31, 2020, with an additional $50 million available through a line of credit [32][44] Business Line Data and Key Metrics Changes - OMIDRIA sales in Q4 2020 were $10.6 million, reflecting customer demand despite limited utilization due to reimbursement uncertainties [31][43] - The company reduced its previously recorded reserve for wholesale returns by $5.7 million following confirmation of separate payment for OMIDRIA [47] - The gross to net deductions for OMIDRIA were consistent with prior quarters, indicating stable pricing and demand dynamics [48] Market Data and Key Metrics Changes - The confirmation of separate payment for OMIDRIA by CMS in December 2020 is expected to lead to increased revenues in Q1 2021 as purchasing facilities resume usage [50][51] - The company anticipates a sustained recovery in purchasing facilities and daily average sales volumes for OMIDRIA [32][51] Company Strategy and Development Direction - Omeros is preparing for the anticipated approval and commercial launch of narsoplimab for TA-TMA, with a PDUFA date set for July 17, 2021 [8][11] - The company is expanding its research into narsoplimab for COVID-19 treatment, recognizing its potential role in addressing endothelial injury syndromes [14][15] - Omeros is also advancing its second-generation MASP-2 antibody, OMS1029, targeting once-monthly or less frequent subcutaneous dosing [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing recovery of OMIDRIA sales and the successful launch of narsoplimab, citing strong engagement from the transplant community [10][50] - The company is aware of the NIH initiative for long-hauler COVID-19 research and sees potential for narsoplimab in preventing and treating long-term sequelae [60][61] - Management noted that enrollment in clinical trials, particularly for IGA nephropathy, has been impacted by hospital restrictions due to the pandemic, but efforts are underway to expand patient access [65][66] Other Important Information - Omeros is actively involved in discussions with regulatory authorities in Europe regarding potential funding and clinical trials for narsoplimab in COVID-19 [20] - The company is monitoring legislative developments related to the No Pain Act, which aims to expand access to non-opioid pain management drugs like OMIDRIA [34][96] Q&A Session Summary Question: Can you provide clarity on OMIDRIA sales during the fourth quarter? - Management acknowledged that the uncertainty around reimbursement affected sales, but noted that sales improved after CMS confirmed separate payment in early December [55][56] Question: What is the company's plan for narsoplimab regarding long-haulers? - Management indicated that they are considering studying narsoplimab for long-term sequelae of COVID-19, noting that treated patients showed no evidence of sequelae [60][61] Question: What challenges are being faced in the IGA nephropathy trial enrollment? - Management explained that enrollment challenges are primarily due to hospital-specific restrictions rather than issues related to the disease itself [66][67] Question: What are the expectations for the I-SPY program involving narsoplimab? - Management clarified that the I-SPY trial is independent and aims to assess the effectiveness of drugs in COVID-19, with narsoplimab being the only complement inhibitor involved [74][75] Question: How does the company view the commercialization strategy for OMIDRIA in 2021? - Management stated that the current sales force is sufficient and that they are focusing on partnerships with ASC chains to drive cataract surgery volume [95][96]