Financial Data and Key Metrics Changes - The company reported a net income of $14.8 million for Q4 2023, a significant increase from $3.2 million in the same period last year, resulting in diluted net income per share of $0.49 compared to $0.10 in Q4 2022 [6][28] - Total revenue for Q4 was $192.5 million, representing a 40% increase from $137.9 million in Q4 2022 [24][108] - Full year revenue for 2023 totaled $624.8 million, a 53% increase over $407.9 million in 2022 [109] Business Line Data and Key Metrics Changes - US revenue in Q4 was $189.4 million, a 41% increase from $134.3 million in the prior year period, driven by higher utilization at existing centers and the addition of new implanting centers [24][108] - International revenue decreased by 16% to $3.1 million due to delays in EU MDR approval affecting shipments [9][74] Market Data and Key Metrics Changes - The average selling price (ASP) in the US for Q4 was $25,000, slightly up from $24,900 in the prior year, while the ASP outside the US was $19,900, down from $20,400 [9] - The company expects full year revenue for 2024 to be in the range of $775 million to $785 million, representing a 24% to 26% increase compared to 2023 [10][105] Company Strategy and Development Direction - The company plans to focus on increasing procedure volumes at existing centers while training and opening new implanting centers, with expectations to activate 52 to 56 new centers per quarter in 2024 [83][87] - The introduction of the SleepSync digital platform aims to enhance patient experience and streamline management [8][107] - The Inspire V system is expected to have a limited market release in 2024, with a full launch targeted for 2025 [76][116] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving steady profitability in the second half of 2024, driven by improved operating leverage and strong patient demand [29][105] - The company anticipates pronounced seasonality in Q1 2024, following a strong Q4 2023, but expects to return to growth thereafter [29][100] Other Important Information - The company has onboarded a third-party vendor to assist with the prior authorization process, enhancing capacity to meet growing patient demand [7] - The gross margin for Q4 was 85.4%, up from 83.9% in the prior year, attributed to improved manufacturing yields and higher volumes [86] Q&A Session Summary Question: Can you provide more detail on the 2024 guidance? - Management indicated that the guidance includes expectations for utilization growth and the impact of label expansion and the Gen 5 launch [11][12] Question: What is the status of the Inspire V submission to the FDA? - The company is completing final testing and documentation for the Inspire V submission, targeting approval for a limited launch in 2024 [14][116] Question: How are investments in sleep centers performing? - Management noted that investments in sleep centers are aimed at easing bottlenecks and improving patient throughput, with ongoing education for sleep physicians [47][120] Question: What impact do you foresee from competition in the market? - The company is aware of competition and believes its clinical evidence remains superior, focusing on patient care and therapy adoption [140][158] Question: How will the new policy changes by UnitedHealthcare affect patient flow? - Management does not anticipate significant impact from UnitedHealthcare's new requirements, as most patients have already attempted CPAP therapy [142][161]
Inspire(INSP) - 2023 Q4 - Earnings Call Transcript