Inspire Medical Systems Inc 2025年季度报告

(Mark One)☒QUARTERLY REPORT PURSUANT TO SECTION13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF1934For the quarterly period endedMarch 31, 2025or If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying with any new or revised financial accounting standards provided pursuant to Section13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Exchange Act). Yes☐No☒ As of April30, 2025, the registrant had29,493,924shares of common stock, $0.001 par value per share, outstanding. Table of Contents FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q (the "Quarterly Report") contains forward-looking statements within the meaning ofthe Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safeharbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the including, without limitation, statements regarding our future results of operations and financial position, business strategy,the impact of macroeconomic trends on our business, financial results and financial position, prospective products, international product approvals and commercializations, our expectations regarding reimbursement levels for Inspiretherapy procedures, research and development costs, timing and likelihood of success, other insurance providers' plansto begin covering our Inspire therapy, our sales and marketing initiatives, potential supply chain disruptions, and the plans In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “can,” “continue,”“could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,”“project,” “should,” “target,” “will,” “would,” or the negative of these terms or other similar expressions, although not allforward-looking statements contain these words. The forward-looking statements in this Quarterly Report are onlypredictions and are based largely on our current expectations and projections about future events and financial trends that •our history of operating losses and dependency on our Inspire system for revenues; •commercial success and market acceptance of our Inspire therapy; •our ability to achieve and maintain adequate levels of coverage or reimbursement for our Inspire system or anyfuture products we may seek to commercialize; •competitive companies, technologies, and pharmaceuticals in our industry;•our ability to expand our indications and develop and commercialize additional products and enhancements to ourInspire system; •future results of operations, financial position, research and development costs, capital requirements, and ourneeds for additional financing; •our ability to forecast customer demand for our Inspire system and manage our inventory;•our dependence on third-party suppliers, vendors, and contract manufacturers;•risks related to consolidation in the healthcare industry; •our ability to expand, manage, and maintain our direct sales and marketing organization, and to market and sellour Inspire system in markets outside of the United States; •our ability to manage our growth; •our ability to hire and retain our senior management and other highly qualified personnel; •risks related to product liability claims and warranty claims; •our ability to address quality issues that may arise with our Inspire system; •our ability to successfully integrate any acquired business, products, or technologies; •changes in global macroeconomic conditions; •any failure of key information technology systems, processes, or sites or damage to or inability to access ourphysical facilities; •our ability to commercialize or obtain regulatory approvals or certifications for our Inspire therapy and system, orthe effect of delays in commercializing or obtaining regulatory approvals or certifications; •any violations of anti-bribery, anti-corruption, and anti-money laundering laws;•our ability to use our net operating losses and research and development carryforwards; •risks related to the increasing and evolving focus on sustainability and environmental, social, and governanceinitiatives; •U.S. Food and Drug Administration ("FDA") or other United States or foreign regulatory actions affecting us or thehealthcare industry generally, including risks associated with regulatory approvals, certifications, or healthcare •our ability to establish and maintain intellectual property protection for our Inspire therapy and system or avoidclaims of infringement; •changes in U.S. and foreign tax laws;•risks related to our common stock; and •other important factors that could cause actual results, performance, or achievements to differ materially fromthose contemplated that are found in "Part I, Item 1. Business," "Part I,