OptiNose(US:OPTN)2021-03-03 20:27Financial Data and Key Metrics Changes - For the full year 2020, XHANCE net revenues increased by 59% to $48.4 million compared to 2019, with total prescriptions rising by 70% and new prescriptions by 31% [6][8] - Operating expenses for 2020 were $129 million, a 3% increase from 2019, reflecting disciplined expense management despite pandemic challenges [8][32] - Average net revenue per prescription for Q4 2020 was $211, while the full year average was $185, a decrease of 6% from 2019 [31][39] Business Line Data and Key Metrics Changes - New prescriptions for XHANCE reached 24,600 in Q4 2020, a 7% increase from Q3 2020 and a 16% increase from Q4 2019, marking the highest quarterly new prescriptions since launch [19][20] - Refill prescriptions increased to 49,300 in Q4 2020, comprising approximately two-thirds of the XHANCE business [21] - Total XHANCE prescriptions in Q4 2020 were approximately 73,900, representing a 36% growth over Q4 2019 [22] Market Data and Key Metrics Changes - XHANCE market share increased from 3.4% in Q4 2019 to 5.1% in Q4 2020, despite a declining overall market [25] - The breadth of physician prescribing grew, with approximately 6,700 physicians having patients fill at least one prescription of XHANCE, a 14% increase from Q4 2019 [27] Company Strategy and Development Direction - The company aims to drive revenue growth for XHANCE and complete clinical trials for chronic sinusitis, with expectations for improved business conditions in 2021 [61] - The partnership with Kaleo is expected to enhance market access and prescription growth as pandemic conditions improve [13][68] - The company is focused on expanding its target physician audience to approximately 18,000, including additional physicians reached through the Kaleo partnership [23][90] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for 2021, anticipating a gradual return to pre-pandemic norms and increased patient volumes [66][69] - The company expects to achieve at least $80 million in net revenues for 2021, with potential upside driven by improved market conditions and recognition of XHANCE's role in treatment [34][67] Other Important Information - The company expects top-line data from at least one pivotal clinical trial for chronic sinusitis by the end of 2021, despite delays due to the pandemic [18][48] - OPN-019, a new product candidate, is being developed for potential use in COVID-19 prevention and treatment, with a pilot clinical trial expected to start in April 2021 [52][55] Q&A Session Summary Question: What gives confidence in achieving at least $80 million in revenue for 2021? - Management indicated that the $80 million floor reflects current market conditions and anticipated improvements in patient volumes and access to physician offices as the year progresses [66][67] Question: What is the enrollment status for the chronic sinusitis trials? - Management expects to complete enrollment around mid-year, with top-line data anticipated by year-end [71][72] Question: Where are share gains coming from in a declining category? - Share gains are attributed to increased usage from existing prescribers and the addition of new prescribers, with expectations for further growth as access improves [78][79] Question: What portion of prescriptions are currently off-label for chronic sinusitis? - Approximately one-third of prescriptions are specifically coded for nasal polyps, with some off-label use for chronic rhinosinusitis [80] Question: How is data quality being managed in clinical trials during the pandemic? - The company is implementing measures to ensure data quality and patient enrollment despite challenges posed by the pandemic [84]