Timothy Herbert
Analyst · Stifel
Thank you, Ezgi, and thanks, everyone, for joining us today. On the call today, I will provide some key takeaways of our second quarter results and updated outlook before providing an update on coding and reimbursement. I'll then turn the call over to Matt, who will provide additional insights on our second quarter and full year financials. We will then open the call up for questions. Prior to discussing the operations of the quarter, we always highlight that the focus of the Inspire team as well as health care professionals is to deliver the highest possible patient outcomes. And during this call, we will highlight the impressive safety and efficacy of the Inspire V system and also the emerging data demonstrating long-term cardiovascular health associated with the use of Inspire therapy. We are pleased to have delivered results ahead of our expectations for the second quarter. During the quarter, we continue to make progress working with our sales team and customers to navigate the evolving coding and reimbursement environment and delivered adjusted operating income and positive cash flow ahead of expectations through continued disciplined cost management. Given our performance, we are increasing our 2026 outlook for revenue, adjusted operating margin and adjusted earnings per share. I'd like to start by providing an update on coding and reimbursement. Let me address this across the short, mid and long terms. In the short term, we are continuing our efforts to provide Inspire V coding and reimbursement education and support to our customers. As we are starting with our highest volume centers, these represent disproportionately higher percentages of our revenue. We have continued to see improved trends in key data points such as prior authorization submissions, and we will continue our support efforts in the second half of the year. The bottom line is enhanced coding and billing clarity for all payers, be it commercial, Medicare Advantage or Government Medicare. Each of the payer groups have coverage policies that clearly identify the coding to be used for Inspire procedures and the confusion created early in the year is being effectively managed. Let me provide a little more detail. The previously announced C-codes are now in place. And importantly, hospital and ASC reimbursement rates remain unchanged. These C-codes have also been adopted into the WISeR system for the 6 applicable states. We believe these changes should significantly reduce any uncertainty regarding the appropriate codes that customers should use for the Inspire V procedures. For surgeon reimbursement, the majority of the medical area contractors or MACs do not require use of a -52 modifier when billing CPT code 64582 for Inspire V procedures. Two MACs, however, currently require the modifier. Based on available data, the payment reduction applied by those MACs has ranged from 0% to 30% of the current national average Medicare payment of $723. We have placed significant emphasis on educating customers regarding the documentation requirements and related considerations for reporting Inspire V procedures using CPT code 64582 with the -52 modifier. Turning to midterm actions. CMS has issued its proposed 2027 OPPS and PFS reimbursement rates. For Medicare facility reimbursement, CMS has proposed increasing hospital outpatient reimbursement for the Inspire V procedure to $35,414, an increase of approximately $3,900 or 12% over 2026 rates. CMS has also proposed increasing ASC reimbursement to $31,722, which is an increase of approximately $4,200 or 15% increase over 2026 rates. While these proposed increases are very encouraging, we are not making any assumptions regarding future reimbursement levels until CMS publishes its final rates in November. On the physician fee schedule, CMS has proposed 2027 physician reimbursement of approximately $699 for CPT code 64582. This represents a year-over-year decrease of approximately 4%, driven primarily by a reduction in the physician RVU rate as with the physician reimbursement proposals. The final physician reimbursement rates will be published in November. Looking further ahead, we are focused on supporting the development of a new Category 1 CPT code for a single lead Inspire system. As a reminder, our initial application was not approved at the April AMA CPT Editorial Panel Meeting. Following that decision, we met with reimbursement experts to better understand how we could improve the application and have incorporated that guidance into a revised application, which will be reviewed at the September CPT Editorial Panel Meeting. The revised application addresses 3 key areas. First, it corrects several coding issues related to subcodes for replacement procedures. Second, it is being submitted jointly with another participant in the industry, demonstrating broader stakeholder support. And third, it includes additional clinical evidence that was not presented in the initial submission. If the revised application is approved, the process moves to code valuation and reimbursement review, keeping the proposed new CPT code on track for implementation on January 1, 2028. With coding clarification improving, we feel we can more aggressively refocus our efforts on improving patient flow and revenue growth. As such, and aligning with our earnings results, we are announcing a strategic growth plan called Project Horizon, which is intended to accelerate revenue growth by investing in initiatives designed to enhance patient flow. We are creating this capacity by optimizing our organizational structure to better align resources with revenue growth initiatives. In addition, we are optimizing our supply chain by consolidating production to support quality, scale and efficiency. Through the actions of Project Horizon, we expect to create $30 million of annualized growth investment capacity, which we intend to invest in areas that we believe have the largest growth opportunities for us to further penetrate the OSA market. Our primary area of focus will be expanding patient access to care, improving patient education and engagement and helping appropriate patients navigate the treatment journey with the information they need to make informed decisions about Inspire therapy. Although Project Horizon is still in its early stages, and we are continuing to refine our growth investment priorities, one area where we have already seen encouraging results is the addition of prior authorization support capabilities within the SleepSync platform. These tools help support patients as they navigate the coverage approval process and have been very well received during the pilot phase. Based on that early success, we are increasing our investment in this initiative to further facilitate patient access to therapy. Another example is Inspire Connect, a program designed to enhance the post-implant patient experience for providing patients with timely education and support throughout their Inspire journey. The program is intended to help standardize key aspects of the patient experience by engaging with patients at appropriate intervals following implant to ensure that they have the information and resources needed to understand what to expect during activation and acclamation process. We believe this additional support can improve patient confidence and preparedness, helping patients make informed decisions and navigate their therapy journey more effectively. As we move forward with Project Horizon and our efforts to reinvigorate revenue growth, I look forward to providing additional updates on these and other initiatives as investments that will support our long-term growth strategy. Switching to patient outcomes. We remain excited about the clinical outcome data on Inspire V. At the recent American Academy of Sleep Medicine Conference in Baltimore in June, we presented the full results from the Inspire V trial conducted in Singapore. While we have previewed some of the early data points, including inspiratory overlap, this was the first time we showed the full trial results, including the ability of the new accelerometer-based sensing technology and the safety and efficacy of the Inspire V implant. In addition, multiple presentations highlighted the growing body of evidence supporting Inspire therapy, particularly in improving cardiovascular risk markers. Separately, Inspire highlighted additional research at its exhibit booth, including recent peer-reviewed articles on hypoxic burden and cardiovascular outcomes. The first article I want to highlight was a secondary analysis from the STAR trial that demonstrated significant reductions in hypoxic burden, a key measure of the total impact of oxygen desaturation events during sleep, integrating the depth, duration and frequency of these events to quantify sleep apnea severity. These findings reinforce hypoxic burden as an emerging and clinically relevant endpoint and align with a growing number of studies evaluating cardiovascular outcomes in patients treated with Inspire therapy versus continuous positive airway pressure and untreated populations. Another article compared clinical outcomes between hypoglossal nerve stimulation and CPAP in OSA patients using data from the TriNetics database and compared a masked group of 3,525 patients in each group. The findings demonstrated that the hypoglossal nerve stimulation cohort has significantly lower odds of several factors, including stroke, myocardial infarction, atrial fibrillation, hospitalization, acute heart failure and others. The conclusion was that hypoglossal nerve stimulation may offer systemic benefits and reduce health care burden compared to CPAP. We also are excited to announce the publication of the PREDICTOR study, which identified body mass index and neck circumference as predictors of complete concentric collapse. These findings suggest that many patients may be screened for Inspire therapy eligibility without requiring drug-induced sleep endoscopy, potentially reducing diagnostic burden, time to treatment and health care costs. A big contributor to our strong body of clinical evidence is our dedication to be at the forefront of innovation in OSA. As such, we continue to make progress with our research and development efforts in 2026 with ongoing work on Inspire V. Before I wrap up, I want to thank Casey Tansey for over 18 years of service on our Board of Directors. Casey was one of the first venture investors to recognize the potential impact of Inspire therapy, led the Series A financing back in 2007 and has provided years of valuable mentorship, leadership and perspective. At the same time, we are excited to welcome Mike Carroll to our Board of Directors. Mike is a veteran of the medical device industry with significant executive leadership and Board experience, and we look forward to his guidance and contributions to our Board. In closing, we continue to believe that there is a large untreated population of people struggling with sleep apnea that can benefit from Inspire therapy, and we continue to be encouraged by the strong adoption of Inspire V and the positive data we continue to collect. We remain focused on investing in our growth and providing the best therapy for patients and helping our customers navigate what we believe will be a temporary market disruption related to coding and reimbursement. We are actively addressing the challenges posed by this disruption, and we remain excited about our product and the market opportunity to improve the lives of our patients as we've already done for over 140,000 patients since our inception. We will continue to take actions to position the company for long-term profitable growth and believe that we have the right strategies in place to drive long-term stakeholder value. I will now turn the call over to Matt.