Inspire Medical Systems Files 2024 Annual Report

Ticker: INSP · Form: 10-K · Filed: Feb 10, 2025 · CIK: 1609550

Inspire Medical Systems, INC. 10-K Filing Summary
FieldDetail
CompanyInspire Medical Systems, INC. (INSP)
Form Type10-K
Filed DateFeb 10, 2025
Risk Levellow
Pages15
Reading Time18 min
Key Dollar Amounts$0.001
Sentimentneutral

Sentiment: neutral

Topics: annual-report, sec-filing, medical-devices

Related Tickers: INSP

TL;DR

Inspire Medical Systems (INSP) filed its 2024 10-K. All good on the reporting front.

AI Summary

Inspire Medical Systems, Inc. filed its annual report for the fiscal year ended December 31, 2024. The company is incorporated in Delaware and headquartered in Golden Valley, MN. Its common stock is traded on the New York Stock Exchange under the ticker symbol INSP. The filing indicates the company has met all reporting requirements for the preceding 12 months and 90 days.

Why It Matters

This 10-K filing provides a comprehensive overview of Inspire Medical Systems' financial performance and operational status for the fiscal year 2024, crucial for investors assessing the company's health and future prospects.

Risk Assessment

Risk Level: low — The filing is a standard annual report and does not contain immediate red flags, indicating a low level of immediate risk from this document alone.

Key Numbers

Key Players & Entities

FAQ

What is the primary business of Inspire Medical Systems, Inc.?

The filing does not explicitly state the primary business, but the company name suggests it is involved in medical systems.

Where is Inspire Medical Systems, Inc. headquartered?

The company's principal executive offices are located at 5500 Wayzata Blvd., Suite 1600, Golden Valley, MN 55416.

On which stock exchange is Inspire Medical Systems, Inc. traded?

Inspire Medical Systems, Inc.'s common stock is traded on the New York Stock Exchange.

What is the par value of Inspire Medical Systems, Inc.'s common stock?

The par value of Inspire Medical Systems, Inc.'s common stock is $0.001.

Has Inspire Medical Systems, Inc. met its filing requirements for the past 12 months?

Yes, the filing indicates that the registrant has filed all reports required by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months.

Filing Stats: 4,427 words · 18 min read · ~15 pages · Grade level 14.7 · Accepted 2025-02-10 16:23:40

Key Financial Figures

Filing Documents

Forward-Looking Statements

Forward-Looking Statements 4 Summary Risk Factors 4 PART I Item 1.

Business

Business 6 Item 1A.

Risk Factors

Risk Factors 31 Item 1B. Unresolved Staff Comments 71 Item 1C. Cybersecurity 71 Item 2.

Properties

Properties 72 Item 3.

Legal Proceedings

Legal Proceedings 72 Item 4. Mine Safety Disclosures 72 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 72 Item 6. [Reserved] 74 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 75 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 86 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 88 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 116 Item 9A.

Controls and Procedures

Controls and Procedures 116 Item 9B. Other Information 120 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 120 PART III Item 10. Directors, Executive Officers and Corporate Governance 120 Item 11.

Executive Compensation

Executive Compensation 120 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 121 Item 13. Certain Relationships and Related Transactions, and Director Independence 122 Item 14. Principal Accountant Fees and Services 122 PART IV Item 15. Exhibits and Financial Statement Schedules 123 Item 16. Form 10-K Summary 125

Signatures

Signatures 126 Table of Contents

Forward-Looking Statements

Forward-Looking Statements This Annual Report on Form 10-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the "Securities Act") and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). All statements other than statements of historical fact contained in this Annual Report on Form 10-K are forward-looking statements, 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 the final reimbursement levels for Inspire therapy procedures, research and development costs, timing and likelihood of success, other insurance providers' plans to begin approving our Inspire therapy, human capital initiatives, pay equity reviews, environmental, social, and governance reporting, our sales and marketing initiatives, potential supply chain disruptions, and the plans and objectives of management for future operations. 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 all forward-looking statements contain these words. The forward-looking statements in this Annual Report on Form 10-K are only predictions and are based largely on our current expectations and projections about future events and financial trends that we belie

Business

Item 1. Business. Overview We are a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea ("OSA"). Our proprietary Inspire system is the first and only FDA, European Union ("EU") Regulation No. 2017/745 ("MDR" or "EU Medical Devices Regulation"), and Japan Pharmaceuticals and Medical Devices Agency-approved neurostimulation technology of its kind that provides a safe and effective treatment for patients with moderate to severe OSA. We have developed a novel, closed-loop solution that continuously monitors a patient's breathing and delivers mild hypoglossal nerve stimulation to maintain an open airway. A significant body of clinical data, which includes a publication in the New England Journal of Medicine , multiple publications in leading respiratory, ear, nose and throat ("ENT") and sleep medicine journals, and more than 350 peer-reviewed publications, supports the safety and efficacy of Inspire therapy. Inspire therapy received premarket approval ("PMA") from the FDA in 2014 and has been commercially available in certain European markets since 2011. Japan's Ministry of Health, Labour and Welfare ("MLHW") approved Inspire therapy to treat moderate to severe OSA in 2018. Inspire therapy is indicated for patients with moderate to severe OSA who do not have significant central sleep apnea and do not have a complete concentric collapse of the airway at the soft palate level. Physicians have treated more than 90,000 patients with Inspire therapy at over 1,575 medical centers across the United States ("U.S."), Europe, and Asia. Sleep apnea is a serious and chronic disease that negatively impacts a patient's sleep, health, and quality of life. OSA is the most common form of sleep apnea. OSA occurs when a person's breathing is interrupted during sleep by a partially or completely blocked airway and affects patients of all ages, sexes, and body types. The severity

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