Summary of Inspire Medical Systems Conference Call Company Overview - **Company**: Inspire Medical Systems (NYSE: INSP) - **Industry**: Medical Technology, specifically focused on sleep apnea treatment Key Points and Arguments Financial Performance - The company reported a strong quarter following a challenging second quarter due to the transition from Inspire 4 to Inspire 5 systems [4][3] - Patient outcomes from the Inspire 5 device were reported positively from clinical studies in Singapore and initial commercial experiences in the U.S. [4][4] - Over 98% of centers have been trained for Inspire 5, with 90% completing contracting and 75% ready for the Sleep Sync preparation [5][5] Product Transition - The transition from Inspire 4 to Inspire 5 is nearly complete, with most centers now using Inspire 5 [8][7] - The new Inspire 5 system has shown a 20% reduction in surgical time, making it easier for ENTs to perform more procedures [11][12] - The removal of the pressure-sensing lead in Inspire 5 has simplified the procedure, addressing previous discomfort for surgeons [11][12] Market Dynamics - The company is focusing on increasing awareness among ENTs and optimizing their practices to handle more cases [15][17] - Inspire Medical Systems is working to ensure consistent reimbursement policies across major payers, which is crucial for physician adoption [24][24] - The transition to a new reimbursement code (64568) has improved reimbursement rates, particularly for ASCs (Ambulatory Surgical Centers) [28][125] Growth Strategy - Inspire Medical Systems has trained over 1,600 ENT surgeons, with a target market of approximately 12,000 general ENTs and 8,000 head and neck specialists [45][46] - The company is optimistic about expanding its reach to general surgeons and enhancing its market penetration [47][47] - The focus is on community-based care, where the majority of procedures are performed, as these centers drive growth [30][32] Tailwinds and Challenges - The rise of GLP-1 medications has increased awareness of obstructive sleep apnea (OSA), leading to more patients seeking treatment [51][56] - The company anticipates low double-digit revenue growth (10-11%) for the upcoming year, balancing tailwinds from Inspire 5 and headwinds from existing Inspire 4 inventory [82][88] Operational Efficiency - Inspire Medical Systems has improved its operational efficiency, leading to a raised EPS guidance for the year [102][105] - The company is restructuring its commercial organization to enhance the effectiveness of territory managers and field clinical reps [108][111] Future Innovations - Inspire 6 is in development, aiming to automate the device's operation based on patient sleep patterns, which could significantly improve adherence to therapy [160][162] - Recent studies indicate improvements in cardiovascular health among patients using Inspire therapy, which could strengthen the case for payer coverage [164][167] Capital Allocation - The company has a $200 million share repurchase authorization, with $50 million already completed, indicating confidence in its stock valuation [152][152] Additional Important Insights - The company is focusing on direct-to-consumer advertising to increase patient awareness and drive demand for Inspire therapy [138][146] - The transition to Inspire 5 is expected to enhance patient outcomes and streamline procedures, which is critical for long-term growth [160][162]

Core Insights - The company reported strong third-quarter results with a revenue of $224.5 million, a 10% increase year-over-year, and reaffirmed its full-year revenue guidance of $900 to $910 million, representing a growth of 12% to 13% compared to 2024 [8][15][18] - The Inspire 5 system has shown significant clinical performance improvements, including an 87% inspiratory overlap with patient breathing and a 20% reduction in surgical times [4][5] - The company is experiencing positive feedback from clinical studies, indicating that Inspire therapy can reduce long-term cardiovascular morbidity and mortality compared to CPAP treatment [6][7] Financial Performance - Total revenue for the third quarter was $224.5 million, with U.S. revenue at $214.4 million, a 9% increase from the previous year [15] - Operating income for the quarter was $9.6 million, down from $14.3 million in the prior year, with net income at $9.9 million compared to $18.5 million [16][17] - The company increased its earnings per share guidance to 90¢ to $1, up from a previous range of 40 to 50¢ [8][19] Market and Product Development - The Inspire 5 launch is progressing well, with over 98% of physician training completed and over 75% of centers onboarding SleepSync [7][8] - The company is focusing on expanding its market access and has seen a positive trend in reimbursement, with CMS finalizing an 11% increase for CPT code 64568 [9][10] - The company is also leveraging the growing interest in sleep health driven by GLP-1 treatments, which is bringing more patients into clinics [11][12] Strategic Initiatives - The company is committed to enhancing patient outcomes through innovation and clinical evidence, with ongoing investments in medical education and patient marketing [7][13] - A new advertising campaign has been launched to promote Inspire therapy, featuring notable partnerships to increase awareness [9] - The company is actively working to transition centers from Inspire 4 to Inspire 5, with a focus on training and support for lower-volume centers [40][41] Future Outlook - The company anticipates a revenue growth of 10% to 11% for 2026, influenced by the ongoing adoption of Inspire 5 and the impact of GLP-1 treatments [22][23] - The company is monitoring competitive dynamics and expects to provide formal guidance for 2026 in January [22][58] - The company is also addressing operational efficiencies through territory management and optimizing the ratio of territory managers to field clinical representatives [77][78]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $224.5 million, a 10% increase from $203.2 million in Q3 2024 [15] - U.S. revenue was $214.4 million, up 9% from $195.8 million in the prior year [15] - Gross margin improved to 85.8% from 84.1% year-over-year, driven by increased sales volume and a favorable sales mix of Inspire 5 [15] - Operating income decreased to $9.6 million from $14.3 million in the prior year [16] - Net income for the quarter was $9.9 million, down from $18.5 million year-over-year [16] - Adjusted EBITDA was $44 million, slightly down from $44.5 million in the prior year [17] - The company increased its earnings per share guidance to $0.90-$1, up from $0.40-$0.50 previously [9] Business Line Data and Key Metrics Changes - Inspire 5's U.S. launch showed significant progress, with physician training over 98% complete and contracting over 90% complete for centers [8] - The Inspire 5 system demonstrated an 87% inspiratory overlap with patients' breathing, indicating strong clinical performance [5] - The company reported a 20% reduction in surgical times based on clinical studies [4] Market Data and Key Metrics Changes - Revenue outside the U.S. was $10.1 million, a 37% increase year-over-year [15] - The Centers for Medicare & Medicaid Services (CMS) finalized an 11% increase in the physician fee schedule for CPT code 64568, effective January 1, 2026 [10] Company Strategy and Development Direction - The company remains focused on patient outcomes and innovation, investing in clinical evidence and medical education [4] - Strategies include training advanced practice providers and increasing the capacity of provider partners to treat more patients [13] - The company is optimistic about the future, with plans to drive long-term stakeholder value [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the durability of growth heading into 2026, with an early indication of 10%-11% growth for next year [22] - The company is mindful of near-term factors such as inventory transitions and competitive activity but remains focused on executing its growth strategy [23] - Management highlighted the positive impact of GLP-1s on patient flow into clinics, which could benefit Inspire therapy [12] Other Important Information - The company completed $50 million in share repurchases during the quarter, totaling $125 million year-to-date [17] - The company ended the quarter with $411 million in cash and investments, allowing for continued investment in growth strategies [17] Q&A Session Summary Question: Thoughts on 2026 planning and cadence - Management is focused on finishing Q4 strong and is still early in the 2026 planning process, indicating potential accelerated growth from Q3 [22] Question: Trends in business for October and Q4 guidance - Management noted strong trends with Inspire 5 and expects to see consistent execution and operational benefits from tighter integration across departments [28] Question: Transitioning centers to Inspire 5 - Management confirmed that while many centers are transitioning to Inspire 5, some will continue to use Inspire 4 for economic reasons [32] Question: Operating expenses and sustainability - Management indicated that while there is a focus on expense control, investments in R&D and marketing will continue, with a disciplined approach to spending [36] Question: Impact of new competitors on market growth - Management stated that it is early days for new competitors and they will continue to monitor the situation closely [64] Question: Economic considerations for centers using Inspire 4 - Management clarified that economic factors are more related to site of service reimbursement rather than physician reimbursement rates [82] Question: Operating expenses trend for 2026 - Management expects a slight increase in DTC spending but does not anticipate it to grow at the same rate as revenue [83]

Summary of Key Points from J.P. Morgan MedTech Conference Call Industry Overview - The MedTech sector is experiencing earnings reports from various companies, including large-cap firms like BDX (Becton Dickinson) and ZBH (Zimmer Biomet), as well as several SMid-cap companies such as CVRX, INSP, and others [1][31]. Company-Specific Insights CVRX (CVRX) - CVRX has a strong track record, beating top-line expectations 87% of the time, but has seen an average stock reaction of down 2% post-report [2]. - Guidance for 2Q has been lowered to $55-58 million due to salesforce disruptions, with a forecast of $13.5 million in sales for 2Q, representing a 14% increase year-over-year [2]. Inspire Medical (INSP) - Inspire has beaten top-line expectations 86% of the time, with a positive stock reaction 75% of the time, averaging a +4.9% move [3]. - The focus is on the launch of Inspire 5, with expectations for a ramp-up in the second half of the year [3]. Bioventus (BVS) - Bioventus has beaten on sales 78% of the time, with expectations for an in-line to slightly better quarter, forecasting sales of $146 million [8]. - The company is cautious due to mixed orthopedic prints and lower correlation with large joint manufacturers [8]. Ceribell (CBLL) - Forecasting sales of $20.6 million for 2Q, representing a 35% increase, with gross margin expected at 85.5% [9]. - The company is viewed positively as a high-quality SMid-cap, despite the sector being out of favor [9]. Becton Dickinson (BDX) - BDX has beaten top-line expectations 67% of the time, with a significant concern among investors due to a lack of pre-announcement and potential fundamental weaknesses [12][14]. - The Street forecasts organic growth of +2.9% for the upcoming quarter, which is below previous expectations [14]. Enovis (ENOV) - Enovis has beaten on the bottom line 90% of the time, with expectations for a small beat-and-raise against the Street [18]. - The company is facing pressure from a short report and mixed orthopedic prints from competitors [18]. Insulet (PODD) - Insulet has a strong record, beating top-line expectations 93% of the time, with a forecast of $618.8 million in total revenue for 2Q, a 27% increase [22][23]. - The company is viewed as a top pick due to its competitive advantages in patch pump manufacturing [23]. Zimmer Biomet (ZBH) - Zimmer Biomet has beaten revenues 60% of the time, but investors are frustrated with inconsistent performance [29][30]. - The company is expected to deliver a clean quarter with a slight beat and guidance raise, but there are concerns about the high-end of its growth range [30]. Additional Insights - The overall sentiment in the MedTech sector is cautious, with many companies facing challenges such as salesforce disruptions, mixed orthopedic trends, and investor skepticism [6][14][18]. - There is a notable trend of fund flows out of healthcare and MedTech, impacting stock performance across the sector [23]. Conclusion - The MedTech sector is poised for a series of earnings reports, with varying expectations across companies. While some firms like Insulet and CVRX show strong potential, others like Becton Dickinson and Zimmer Biomet face significant investor scrutiny and challenges. The overall market sentiment remains cautious, reflecting broader economic uncertainties and sector-specific dynamics.