Inspire Medical Systems, Inc.

Good afternoon. My name is Dilem, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Inspire Medical Systems third quarter 2025 conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there'll be a question and answer session. I'll now hand the call over to your first speaker, Eski Yaja, the Vice President of Investor Relations at Inspire. You may begin the conference.

Thank you, Dilem, and thank you all for participating in today's call. Joining me are Tim Herbert, Chairman and Chief Executive Officer, and Rick Buhl, Chief Financial Officer. Earlier today, we released financial results for the three and nine months ended September 30, 2025. A copy of the press release is available on our website. On this call, management will make forward-looking statements within the meaning of the federal securities laws. All forward-looking statements, including without limitation those relating to our operations, financial results and financial condition, investments in our business, full-year 2025 financial and operational outlook, and changes in market access are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ. Accordingly, you should not place undue reliance on these statements. Please see our filings with the Securities and Exchange Commission, including our Form 10-Q, which we filed with the SEC earlier this afternoon, for a description of these risks and uncertainties. INSPIRE disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and speaks only as of the live broadcast today, November 3rd, 2025. With that, it is my pleasure to turn the call over to Tim Herbert. Tim.

Thank you, Esgie. And thanks everyone for joining our business update call for the third quarter of 2025. I'll start by highlighting some key takeaways of our third quarter results. I'll then discuss our updated 2025 guidance and Rick will provide a financial review. We will then open the call up for questions. As always, I want to start by reiterating our commitment to put the patient first and deliver strong patient outcomes. We continue to invest in innovation and clinical evidence as we lead the way in hypoglossal nerve stimulation. And this was on display at the recent ENT society meetings where Inspire 5 performance data were presented. The results of our Singapore clinical study of 44 patients demonstrated significant performance improvements as well as a 20% reduction in surgical times. And early experience from our US limited market release of over 100 patients demonstrated clinically relevant reduction in disease severity with patients averaging over six hours of nightly device use. Furthermore, We presented data showing Inspire 5's 87% inspiratory overlap with the patient's breathing. As many of you already know, this is the foundation of our closed-loop stimulation system. As the airway collapses during the inspiratory phase of respiration, synchronizing stimulation with inspiration is essential to optimize therapy. We are excited and energized by the strong performance of the Inspire 5 system and the clinical feedback on the simplified procedure and comfort settings has been tremendously positive. In addition, Inspire-related publications led the discussions at the EMT meetings, and we were excited to see two academic centers independently found that Inspire is an effective treatment for both supine and non-supine dependent OSA. and that INSPIRE provides clinical benefit regardless of sleep position. Multiple papers demonstrated INSPIRE's ability to improve long-term cardiovascular comorbidities, including a study from the University of Texas Health that assessed over 4,500 patients over a 10-year period in the TRINETX database. This is a large multi-institutional electronic health record network. The study showed that INSPIRE offered advantages in reducing long-term cardiovascular morbidity and mortality in patients of OSA compared to CPAP treatment. In another paper out of Thomas Jefferson University, using the same database, INSPIRE was compared to CPAP and to no treatment. The study demonstrated that INSPIRE was associated with broadly improved non-apneic outcomes compared to CPAP and to no treatment. Specifically, they showed that Inspire therapy resulted in lower risk for myocardial infarction, cardiac arrest, ischemic stroke, and depression, amongst others. Together, these studies are the first evidence that Inspire can reduce cardiovascular morbidity and mortality in the most vulnerable patients namely those who are unable to tolerate CPAP. These outcomes are a testament to the importance of diagnosing and treating OSA and validate the continued investments we're making in innovation, clinical evidence, medical education, and patient marketing. With respect to the Inspire 5 US launch, the team made significant progress in the third quarter, and we are excited to report that physician training is over 98% complete, contracting is over 90% complete for our centers, and sleep-sick onboarding is complete for over 75%, bringing the total to over 75% implanting Inspire 5 today. Given this progress and our strong momentum we are seeing, we are reiterating our full-year revenue guidance of $900 to $910 million representing 12% to 13% growth compared to full year 2024. Switching to our quarterly results, we are very pleased with the strong revenue performance and cost discipline we demonstrated in the quarter. Third quarter revenue totaled $224.5 million, or a 10% increase compared to the prior year period, including the increased investment we are making in patient marketing, We were able to deliver operating income of $9.6 million and earnings per share of 34 cents. This strong performance gives us confidence to increase our earnings per share guidance to 90 cents to $1 up from 40 to 50 cents previously. On patient marketing, we've started rolling out a new ad campaign highlighting the fact that with Inspire, many patients report that they can dream again, complete with a holiday-themed ad featuring none other than Ebenezer Scrooge treating his sleep apnea. You may also have seen our new ad featuring a celebrity influencer partnership with Jacques Chappelle, the winner of last season's Golden Bachelorette, a real Inspire user since 2021. And we are encouraged. by their early indications from these initiatives. Regarding reimbursement, CMS recently finalized the 2026 Physician Fee Schedule at approximately $660, or an 11% increase for CPT code 64568. As you know, for INSPIRE V, centers bill CPT code 64568 which has been accepted for plans covering over 90% of our 300 million covered lives, including Medicare. This change will take effect January 1, 2026. We are still awaiting the final OPPS rules to be issued by CMS. As you know, as you are aware, in July, CMS proposed to increase the national average Medicare hospital reimbursement for CPT code 64568 to $32,000 up approximately $1,300 or 4% from 2025 and the ASC reimbursement to $28,000 up $1,300 or 5% compared to 2025. These positive reimbursement changes will take effect January 1st, 2026 once approved. Following our last earnings call, We conducted our own survey of over 200 sleep physicians to better understand their treatment paradigm for OSA since the introduction of GOP-1s. What we confirmed is that the GOP-1s are driving increasing interest in sleep health and bringing more patients into the clinic, if only to get their GOP-1s covered by insurance with an OSA diagnosis. INSPIRE welcomes this trend as it opens the door to alternatives beyond CPAP. Based on the survey results, about half the sleep physicians now prescribe and manage GLP-1s themselves, while the rest refer patients back to family practice due to the burden of managing these patients, whether it's insurance hurdles, challenging side effects, or because weight management just is not their area of focus. The survey also identified that sleep physicians are not comfortable prescribing GOP1s alone, but prescribe concurrently with other treatment options, initially CPAP. Patient monitoring, coupled with the insurance requirements to obtain refill prescriptions, provide visibility into the patient's weight loss, adherence to CPAP, and overall sleep health. These same physicians then understand the patient profile that may be recommended for Inspire Therapy. Overall, the survey confirmed that patients will try a GLP-1 prior to surgery, but also the patient pool has been increasing with the availability of GLP-1s to treat OSI. This reinforces our confidence that GLP-1s make it possible for higher BMI patients to lose weight and become eligible for Inspire Therapy, and Inspire is excited to help even more patients access effective lasting care. In summary, we remain focused on the patient to continue the growth and 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 adoption of SleepSync and our digital tools, all of which are embedded strategies in our commercial team's objective to increase provider capacity. Looking ahead, we are confident about our future in that we have the appropriate strategy in place to drive long-term stakeholder value. We have our arms around the headwinds that I have described, and actions are already underway to accelerate adoption of Inspire 5 for the remainder of the year. And looking beyond 2025, we continue to take action to position the company for strong, profitable growth. With that, I'd like to turn the call over to Rick for his review of our financials.