Timothy Herbert
Analyst · Piper Sandler
Thank you, Ezgi, and thanks, everyone, for joining our business update call for the fourth quarter and full year 2025. On this call, I will start by providing an update on reimbursement of our Inspire V system followed by some key takeaways of our fourth quarter and full year results. Then Matt will provide a financial review of our fourth quarter and full year 2025 results and our full year 2026 outlook. We will then open the call for questions. The key challenge for our business since late last year is, of course, the coding of the Inspire V procedure. A few weeks ago at an investor conference, we shared that we were actively engaging with key government agencies and physician societies regarding the use of CPT code 64568 -- sorry, had a bug, versus CPT code 64582 with a -52 modifier for the Inspire V procedure. In the last week, we received clarification regarding the coding that should be used for the Inspire V procedure. Currently, health care centers and physicians should bill the most recent health care policies, be it a MAC or a commercial payer. Based on the clarification, we believe the code will transition to CPT code 64582 for the Inspire V procedure, including the use of a -52 modifier. We estimate that the reduction to the professional fee associated with applying the -52 modifier could range from approximately 10% to 50% of the base rate. The actual reduction may vary by MAC, and we will not know the precise impact until sufficient claims data have been submitted and processed across payers. In any case, we believe that a significant decrease in the professional fee resulting from use of the -52 modifier will likely influence physicians' willingness to perform the Inspire V procedure and may limit the number of cases they choose to undertake. We intend to address these challenges by focusing on short- and long-term initiatives. Over the short term, as we work through 2026, we plan to work with the appropriate stakeholders on initiatives intended to minimize the actual reduction applied to the professional fee as well as to drive consistency across the country. As an initial observation, we believe there is strong justification for applying a smaller reduction given the markedly higher surgical skill and complexity associated with implanting the stimulation lead compared to the sensing lead. Furthermore, because of the excellent progress made with the launch of Inspire V to close out 2025, significant coding experience now exists for the Inspire V procedure. CPT code 64568 was used for approximately 10,000 Inspire V procedures in 2025, which provides a basis for professional reimbursement. The professional fee for CPT code 64568 is approximately 10% less than the reimbursement for CPT code 64582 used for Inspire IV procedures and reflects the reduced work associated with implanting the pressure sensing lead. As a note, we are nearing the completion of manufacturing of the Inspire IV systems. However, we believe that we have sufficient inventory available for centers who may choose to remain with the Inspire IV system for the foreseeable future. Given this dynamic reimbursement landscape, we have revised and widened our full year revenue guidance for 2026 to reflect the broad range of possible impacts that we may experience throughout the year. Over the long term, we will be focused on developing a new CPT code. With clarity on the coding of Inspire V procedures as well as hospital and ASC site of service reimbursement and an action plan to clarify the professional fee payment, we can return to patient care, and I will start by reiterating our commitment to put the patient first and deliver strong patient outcomes. Over the past few months, we had the privilege to show data from the Singapore study and the U.S. limited market release, and we are excited and energized by the strong performance of the Inspire V system. Being more specific, the Inspire V system has demonstrated superiority over Inspire IV as the data has shown a reduction in surgical time with the Inspire V system Inspiratory overlap, which is the essential factor for closed-loop therapy has shown to be significantly improved with the Inspire V system. And the AHI in the Singapore study has demonstrated a 79.5% responder rate using the share criteria, which is far superior to the 66% responder rate demonstrated in the STAR Phase III pivotal trial in 2012. Inspire system reliability continues to improve year-over-year, and the 2025 data to date has shown a 0.5% occurrence of device explants and a 1.5% occurrence of revisions. With respect to the Inspire V U.S. launch, the team has made significant progress in the fourth quarter, and we are excited to report that physician training is complete, contracting is over 95% complete for our centers and SleepSync onboarding is complete for over 90%, bringing the total to over 90% of our centers implanting Inspire V to date. We expect to have stable product inventory for Inspire V throughout 2026, and we anticipate transitioning the existing Inspire IV IPG line to Inspire V later in 2026. Switching to our quarterly results. We are very pleased with the strong revenue performance and cost discipline we delivered in the fourth quarter, which enabled us to deliver positive operating income and earnings. We ended the year with 295 U.S. territories and 275 U.S. field clinical representatives. As we enter 2026, we are being more strategic in our approach to territory management and optimizing our model through targeted territory consolidation and increased field clinical reps. We hired seven field clinical reps in the quarter, consistent with our strategy to get the ratio closer to 1:1 territory manager to field clinical rep. On patient marketing, we had a very strong finish to 2025 regarding patient demand for Inspire therapy, including a significant increase in the fourth quarter in social media activity. We believe that this increase is related to the incremental growth investments we made in the back half of 2025. The WISeR program, which is a government initiative requiring prior authorization of Medicare cases in six pilot states kicked off in mid-January of 2026. To date, many Medicare cases have been submitted and approved. However, there have also been denials for multiple reasons, including medical criteria inconsistencies in the AI software as well as coding. We continue to provide prior authorization support to our centers as they work through the WISeR implementation, and we'll update you as we have more information. but the WISeR program has affected Medicare patient procedures in these six states in the first quarter. With respect to our R&D initiatives, we recently began testing a prior authorization feature in SleepSync, which will provide a simplified uploading of patient data to support preparation of prior authorization submissions. We believe this is an important initiative to enhance patient access to Inspire therapy, and we continue to look for additional ways to increase the utility of SleepSync. We are also excited to announce that we recently received FDA approval for 3 Tesla MRI compatibility. In addition, in 2026, one of our primary product development programs will be Inspire VI, which will include sleep detection and auto activation, meaning the device will turn itself on when the patient falls asleep and turn itself off when the patient awakens, maximizing therapy adherence. In summary, we remain focused on the patient to continue the growth in the adoption of Inspire therapy. We will execute our growth strategy of driving high-quality patient flow and increasing the capacity of our provider partners to effectively treat and manage more patients. Our key strategies include training advanced practice providers, certifying additional surgeons qualified to implant Inspire therapy and driving the adoption of SleepSync and our digital tools all of which are embedded strategy in our commercial team's objective in enhancing patient access to Inspire therapy. Looking ahead, we are excited about our future, and we believe that we have the appropriate strategies in place to drive long-term stakeholder value, and we are focused on addressing reimbursement, as I described above. Looking beyond 2026, we continue to take actions to position the company for profitable growth. As we close 2025, I would like to thank Rick Buchholz for his many years at Inspire. With the close of 2025, Rick will move on to his new opportunity, and we wish him well. He joined Inspire in 2014 and was a key contributor to bringing Inspire to where it is today. With that, it is also my pleasure to introduce you to Matt Osberg for his initial earnings call at Inspire.