Company: INSP
Filing Date: 2025-08-04
Form Type: 10-Q
Source: 0001609550-25-000032
Chunk: 144

Company: Inspire Medical Systems, Inc.
Filing Date: 2025-08-04
Form: 10-Q
Item: Part I, Item 3
Chunk 144
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 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 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 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 were using their existing inventory of our Inspire IV system ("Inspire IV") prior to purchasing Inspire V systems. We