Inspire Medical Systems Inc

Item 1A. Risk Factors.

For a discussion of our potential risks and uncertainties, see the information in "Part I, Item 1A. Risk Factors in our Annual Report. There have been no material changes to the risk factors disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, other than the following:

Our financial results may fluctuate significantly and may not fully reflect the underlying performance of our business.

42

Our quarterly and annual results of operations have in the past and may in the future vary significantly and future period-to-period comparisons of our operating results may not be meaningful. Accordingly, the results of any one quarter or period should not be relied upon as an indication of future performance. Our quarterly and annual financial results may fluctuate as a result of a variety of factors, many of which are outside our control and, as a result, may not fully reflect the underlying performance of our business. Such factors may include, for example, seasonal variations in our sales or required postponements of elective surgical procedures effected during a health crisis, as was the case with COVID-19. We generally experience and may in the future experience higher sales in the U.S. during the fourth quarter as a result of patients having paid their annual insurance deductibles in full, thereby reducing their out-of-pocket costs. Alternatively, in the first quarter, many U.S. patients' insurance deductibles reset, requiring more out-of-pocket costs, which negatively impacts our sales during this period.

Other factors that may cause fluctuations in our quarterly and annual results include, but are not limited to:

changes in coverage policies by third-party payors that affect the reimbursement of procedures using our products;

challenges experienced by patients in obtaining positive coverage and reimbursement decisions from payers, including necessary prior authorization approvals in advance of treatment;

timing of new product offerings, acquisitions, licenses or other significant events by us or our competitors;

patients opting to delay implants of our devices in advance of the commercial launch of new products or product generations;

unanticipated pricing pressure;

the hiring, retention, and continued productivity of our sales representatives;

our ability to expand the geographic reach of our sales and marketing efforts;

our ability to obtain regulatory clearance, approval, or certification for any products in development or for our current products for additional indications or in additional countries outside the U.S.;

results of clinical research and studies on our existing products and products in development;

delays in receipt of anticipated purchase orders; and

positive or negative coverage in the media or clinical publications of our products or products of our competitors or our industry.

Beginning late in the first quarter and continuing into the second quarter of 2025, in connection with awareness gained during our ongoing limited market release of the Inspire V system, we began to observe that some patients and physicians are delaying Inspire therapy until our next generation Inspire V is available at their location. Although Inspire V was fully launched in the U.S. in May 2025, an implanting physician and center must meet training, contracting, and onboarding criteria prior to purchasing and implanting Inspire system ("V. We expect to continue to see patients delay Inspire therapy until centers meet these criteria and Inspire V") is available at their location through the end of 2025. Additionally, beginning late in the first quarter and continuing into the second quarter of 2025, we began to observe that some of our customers awere using their existing inventory of our Inspire IV system ("Inspire IV") prior to purchasing Inspire V systems. Whie continued to observe this during the remainder of the second quarter and into the beginning of the third quarter of 2025. While we cannot quantify the impact at this time or predict if these patterns may

39

change, we anticipate that the occurrence of patients and physicians delaying Inspire therapy until Inspire V is available aand the destocking by some of our customers of their existing Inspire IV inventory may impact our consolidated revenue until Inspire V is fully launched anavailable at our customer locations and our customers have used their existing Inspire IV inventory, which iswe expected to primarily occur in the second quarterhalf of 2025.

43

Because our quarterly and annual results may fluctuate, period-to-period comparisons may not be the best indication of the underlying results of our business and should only be relied upon as one factor in determining how our business is performing. These fluctuations may also increase the likelihood that we will not meet our forecasted performance, which could negatively affect the market price for our common stock.