# EDGAR Filing Document

**Accession Number:** 0001609550
**File Stem:** 0001609550-23-000008
**Filing Date:** 2023-1
**Character Count:** 13566
**Document Hash:** f560cd6b7f03e5a9b85144dfe940d267
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001609550-23-000008.hdr.sgml**: 20230109

**ACCESSION NUMBER**: 0001609550-23-000008

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230109

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230109

**DATE AS OF CHANGE**: 20230109

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Inspire Medical Systems, Inc.
- **CENTRAL INDEX KEY:** 0001609550
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **IRS NUMBER:** 261377674
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38468
- **FILM NUMBER:** 23516675

**BUSINESS ADDRESS:**
- **STREET 1:** 5500 WAYZATA BLVD
- **STREET 2:** SUITE 1600
- **CITY:** GOLDEN VALLEY
- **STATE:** MN
- **ZIP:** 55416
- **BUSINESS PHONE:** 763-957-5037

**MAIL ADDRESS:**
- **STREET 1:** 5500 WAYZATA BLVD
- **STREET 2:** SUITE 1600
- **CITY:** GOLDEN VALLEY
- **STATE:** MN
- **ZIP:** 55416

?xml version="1.0" ? insp-20230109

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

_________________________

**FORM 8-K**

_________________________

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of**

**the Securities Exchange Act of 1934**

Date of report (Date of earliest event reported): January 9, 2023

_________________________

**INSPIRE MEDICAL SYSTEMS, INC.**

(Exact name of registrant as specified in its charter)

_________________________

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-38468** | **26-1377674** |
| (State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |

---

**5500 Wayzata Blvd., Suite 1600**

**Golden Valley, Minnesota 55416**

(Address of principal executive offices) (Zip Code)

**(844) 672-4357**

(Registrant's telephone number, including area code)

**N/A**

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐&nbsp;&nbsp;&nbsp;&nbsp;Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐&nbsp;&nbsp;&nbsp;&nbsp;Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ &nbsp;&nbsp;&nbsp;&nbsp;Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐&nbsp;&nbsp;&nbsp;&nbsp; Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock, $0.001 par value per share | INSP | New York Stock Exchange |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company &nbsp;&nbsp;&nbsp;&nbsp;☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition

period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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**Item 2.02.&nbsp;&nbsp;&nbsp;&nbsp; Results of Operations and Financial Condition.**

On January 9, 2023, Inspire Medical Systems, Inc. (the "Company") issued a press release announcing certain preliminary and unaudited results for the quarter and full year ended December 31, 2022. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

**Item 9.01. &nbsp;&nbsp;&nbsp;&nbsp;Financial Statements and Exhibits.**

(d) Exhibits

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | <u>[Press release of Inspire Medical Systems, Inc., dated January 9, 2023.](insp2022-q4prereleaseex991.htm)</u> |
| 104 | Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document. |

---

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**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | | |
|:---|:---|:---|:---|
| | | **INSPIRE MEDICAL SYSTEMS, INC.** | **INSPIRE MEDICAL SYSTEMS, INC.** |
| Date: | January 9, 2023 | By: | /s/ Richard J. Buchholz |
|  |  |  | Richard J. Buchholz |
|  |  |  | Chief Financial Officer |

---

## Exhibit 99.1

**Exhibit 99.1**![new20logo20on20white.jpg](new20logo20on20white.jpg)

**Inspire Medical Systems, Inc. Announces Preliminary Results** 

**for the Fourth Quarter and Full Year 2022**

**MINNEAPOLIS, Minnesota - January 9, 2023** - Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire), a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea, today announced certain preliminary, unaudited results for the quarter and full year ended December 31, 2022.

**Preliminary, Unaudited Revenue and Recent Business Highlights**

• Revenue for the fourth quarter of 2022 is anticipated to be in the range of $137.5 million to $137.9 million, an approximately 76% increase over the same quarter last year

• Revenue for full year 2022 is anticipated to be in the range of $407.5 million to $407.9 million, an approximately 75% increase over full year 2021

• Activated 61 new centers in the U.S. in the fourth quarter of 2022, bringing the total to 905 U.S. medical centers implanting Inspire therapy

• Created 16 new sales territories in the U.S. in the fourth quarter of 2022, bringing the total to 225 U.S. sales territories

• Published inaugural Environmental, Social, and Governance (ESG) Report

"We are very pleased with our strong preliminary revenue performance in the fourth quarter primarily driven by higher utilization at existing centers," said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems. "As we continue to activate new centers, we remain highly focused on consistent patient outcomes and enhanced center efficiencies which are the core of therapy adoption to meet robust demand."

"During the fourth quarter, we activated 61 new U.S. implanting centers, which was above our prior guidance of 52 to 56 new centers per quarter. To further support the growing demand for Inspire therapy, we created 16 new U.S. sales territories in the fourth quarter," continued Mr. Herbert. "Further, we grew revenue in Europe driven primarily by the performance in Germany, Switzerland and the Netherlands."

The preliminary, unaudited revenue results described in this press release are estimates only and are subject to revision until the Company reports its full financial results for 2022 during its earnings announcement planned for Tuesday, February 7, 2023.

Inspire previously announced its participation in the 41<sup>st</sup> Annual J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel in San Francisco, CA, including a formal company presentation at 8:15 a.m. P.T. on Monday, January 9, 2023.

**About Inspire Medical Systems**

Inspire is a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea. Inspire's proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.

For additional information about Inspire, please visit <u>www.inspiresleep.com</u>.

------

**Forward Looking Statements**

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including, without limitation, statements regarding fourth quarter and full year 2022 revenue results. In some cases, you can identify forward-looking statements by terms such as ''may,'' ''will,'' ''should,'' ''expect,'' ''plan,'' ''anticipate,'' ''could,'' "future," "outlook," "guidance," ''intend,'' ''target,'' ''project,'' ''contemplate,'' ''believe,'' ''estimate,'' ''predict,'' ''potential,'' ''continue,'' or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.

These forward-looking statements are based on management's current expectations and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, estimates regarding the annual total addressable market for our Inspire therapy in the U.S. and our market opportunity outside the U.S.; future results of operations, financial position, research and development costs, capital requirements and our needs for additional financing; commercial success and market acceptance of our Inspire therapy; the impact of the ongoing and global COVID-19 pandemic; general and international economic, political, and other risks, including currency and stock market fluctuations and the uncertain economic environment; our ability to achieve and maintain adequate levels of coverage or reimbursement for our Inspire system or any future products we may seek to commercialize; competitive companies and technologies in our industry; our ability to enhance our Inspire system, expand our indications and develop and commercialize additional products; our business model and strategic plans for our products, technologies and business, including our implementation thereof; our ability to accurately forecast customer demand for our Inspire system and manage our inventory; our dependence on third-party suppliers, contract manufacturers and shipping carriers; consolidation in the healthcare industry; our ability to expand, manage and maintain our direct sales and marketing organization, and to market and sell our Inspire system in markets outside of the U.S.; risks associated with international operations; our ability to manage our growth; our ability to increase the number of active medical centers implanting Inspire therapy; our ability to hire and retain our senior management and other highly qualified personnel; risk of product liability claims; risks related to information technology and cybersecurity; risk of damage to or interruptions at our facilities; our ability to commercialize or obtain regulatory approvals for our Inspire therapy and system, or the effect of delays in commercializing or obtaining regulatory approvals; FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the U.S. and international markets; and the timing or likelihood of regulatory filings and approvals. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this press release can be found under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as updated in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, and as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC's website at www.sec.gov and the Investors page of our website at www.inspiresleep.com. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by applicable law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

**Investor & Media Contact**

Ezgi Yagci

Vice President, Investor Relations

<u>ezgiyagci@inspiresleep.com</u>

617-549-2443

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