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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q
________________________________
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31,September 30, 2023 or
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from                             to                              
Commission File Number: 001-38468

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Inspire Medical Systems, Inc.
(Exact name of registrant as specified in its charter)

Delaware26-1377674
(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)
5500 Wayzata Blvd., Suite 1600
Golden Valley, MN
55416
(Address of principal executive offices)(Zip Code)
(844) 672-4357
(Registrant's telephone number, including area code)
N/A
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.001 par value per shareINSPNew York Stock Exchange
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes     No 
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒    No 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☒Accelerated filer ☐Non-accelerated filer ☐Smaller reporting company ☐Emerging growth company ☐
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. 
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes   No 
As of April 25,October 31, 2023, the registrant had 29,172,06429,524,189 shares of common stock, $0.001 par value per share, outstanding.


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Unregistered Sales of Equity Securities and, Use of Proceeds, and Issuer Purchases of Equity Securities
 
 
 
 
 
 

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FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (the "Quarterly Report") 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 facts contained in this Quarterly Report are forward-looking statements, including, without limitation, statements regarding our future results of operations and financial position, business strategy, the impact of the ongoing and global COVID-19 pandemic on our business, financial results and financial position, prospective products, international product approvals and commercialization, 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, environmental, social, and governance reporting, 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 Quarterly Report are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of known and unknown risks, uncertainties, and assumptions, including, but not limited to:
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 any future products we may seek to commercialize;
competitive companies and technologies in our industry;
the impact on our business, financial condition, and results of operation from the ongoing and global COVID-19, pandemic, or any other pandemic, epidemic or outbreak of an infectious disease;
our ability to expand our indications and develop and commercialize additional products and enhancements to our Inspire system;
future results of operations, financial position, research and development costs, capital requirements, and our needs 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 sell our 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;
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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 our physical facilities;
our ability to commercialize or obtain regulatory approvals or certifications for our Inspire therapy and system, or the 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;
the risk that we may be deemed to be an investment company under the Investment Company Act of 1940;
risks related to the increasing and evolving focus on sustainability and environmental, social and governance initiatives;
U.S. Food and Drug Administration ("FDA") or other United States or foreign regulatory actions affecting us or the healthcare industry generally, including risks associated with regulatory approvals or healthcare reform measures in the United States and international markets;
our ability to establish and maintain intellectual property protection for our Inspire therapy and system or avoid claims 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 from those contemplated that are found in "Part I, Item 1. Business," "Part I, Item 1A. Risk Factors," and "Part I, Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as updated by “Part I, Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations" in this Quarterly Report on Form 10-Q.
Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.
You should read this Quarterly Report and the documents that we reference in this Quarterly Report completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Unless the context requires otherwise, references to “Inspire,” the “Company,” “we,” “us,” and “our,” refer to Inspire Medical Systems, Inc.
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PART I—FINANCIAL INFORMATION
Item 1.    Consolidated Financial Statements.
Inspire Medical Systems, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
March 31,
2023
December 31, 2022September 30,
2023
December 31, 2022
(unaudited)(unaudited)
AssetsAssetsAssets
Current assets:Current assets:Current assets:
Cash and cash equivalentsCash and cash equivalents$442,132 $441,592 Cash and cash equivalents$329,897 $441,592 
Investments, short-termInvestments, short-term9,927 9,821 Investments, short-term134,317 9,821 
Accounts receivable, net of allowance for credit losses of
$36 and $36, respectively
59,766 61,228 
Accounts receivable, net of allowance for credit losses of
$1,376 and $36, respectively
Accounts receivable, net of allowance for credit losses of
$1,376 and $36, respectively
71,460 61,228 
Inventories, netInventories, net15,663 11,886 Inventories, net26,115 11,886 
Prepaid expenses and other current assetsPrepaid expenses and other current assets6,090 5,505 Prepaid expenses and other current assets7,802 5,505 
Total current assetsTotal current assets533,578 530,032 Total current assets569,591 530,032 
Investments, long-termInvestments, long-term2,961 — 
Property and equipment, netProperty and equipment, net20,920 17,249 Property and equipment, net32,249 17,249 
Operating lease right-of-use assetsOperating lease right-of-use assets6,614 6,880 Operating lease right-of-use assets23,081 6,880 
Other non-current assetsOther non-current assets10,735 10,715 Other non-current assets11,612 10,715 
Total assetsTotal assets$571,847 $564,876 Total assets$639,494 $564,876 
Liabilities and stockholders' equityLiabilities and stockholders' equityLiabilities and stockholders' equity
Current liabilities:Current liabilities:Current liabilities:
Accounts payableAccounts payable$36,478 $26,847 Accounts payable$40,031 $26,847 
Accrued expensesAccrued expenses23,390 34,339 Accrued expenses29,964 34,339 
Total current liabilitiesTotal current liabilities59,868 61,186 Total current liabilities69,995 61,186 
Operating lease liabilities, non-current portionOperating lease liabilities, non-current portion7,185 7,536 Operating lease liabilities, non-current portion25,173 7,536 
Other non-current liabilitiesOther non-current liabilities146 146 Other non-current liabilities146 146 
Total liabilitiesTotal liabilities67,199 68,868 Total liabilities95,314 68,868 
Stockholders' equity:Stockholders' equity:Stockholders' equity:
Preferred Stock, $0.001 par value, 10,000,000 shares authorized; no shares
issued and outstanding
Preferred Stock, $0.001 par value, 10,000,000 shares authorized; no shares
issued and outstanding
— — 
Preferred Stock, $0.001 par value, 10,000,000 shares authorized; no shares
issued and outstanding
— — 
Common Stock, $0.001 par value per share; 200,000,000 shares authorized; 29,163,001 and 29,008,368 issued and outstanding at March 31, 2023 and December 31, 2022, respectively29 29 
Common Stock, $0.001 par value per share; 200,000,000 shares authorized; 29,403,189 and 29,008,368 issued and outstanding at September 30, 2023 and December 31, 2022, respectivelyCommon Stock, $0.001 par value per share; 200,000,000 shares authorized; 29,403,189 and 29,008,368 issued and outstanding at September 30, 2023 and December 31, 2022, respectively29 29 
Additional paid-in capitalAdditional paid-in capital844,281 820,335 Additional paid-in capital904,293 820,335 
Accumulated other comprehensive income (loss)Accumulated other comprehensive income (loss)32 (86)Accumulated other comprehensive income (loss)44 (86)
Accumulated deficitAccumulated deficit(339,694)(324,270)Accumulated deficit(360,186)(324,270)
Total stockholders' equityTotal stockholders' equity504,648 496,008 Total stockholders' equity544,180 496,008 
Total liabilities and stockholders' equityTotal liabilities and stockholders' equity$571,847 $564,876 Total liabilities and stockholders' equity$639,494 $564,876 
The accompanying notes are an integral part of these unaudited consolidated financial statements.
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Inspire Medical Systems, Inc.
Consolidated Statements of Operations and Comprehensive Loss (unaudited)
(in thousands, except share and per share amounts)
Three Months Ended
March 31,
Three Months Ended
September 30,
Nine Months Ended
September 30,
202320222023202220232022
RevenueRevenue$127,897 $69,382 Revenue$153,302 $109,188 $432,291 $269,956 
Cost of goods soldCost of goods sold19,888 10,004 Cost of goods sold24,382 19,786 68,522 43,963 
Gross profitGross profit108,009 59,378 Gross profit128,920 89,402 363,769 225,993 
Operating expenses:Operating expenses:Operating expenses:
Research and developmentResearch and development25,519 11,870 Research and development29,144 20,993 85,484 47,397 
Selling, general and administrativeSelling, general and administrative101,988 63,564 Selling, general and administrative113,247 85,603 327,853 225,853 
Total operating expensesTotal operating expenses127,507 75,434 Total operating expenses142,391 106,596 413,337 273,250 
Operating lossOperating loss(19,498)(16,056)Operating loss(13,471)(17,194)(49,568)(47,257)
Other expense (income):
Other (income) expense:Other (income) expense:
Interest and dividend incomeInterest and dividend income(4,273)(34)Interest and dividend income(5,495)(1,350)(14,690)(1,681)
Interest expenseInterest expense— 527 Interest expense— 656 — 1,677 
Other (income) expense, net(17)45 
Other expense, netOther expense, net224 101 268 290 
Total other (income) expenseTotal other (income) expense(4,290)538 Total other (income) expense(5,271)(593)(14,422)286 
Loss before income taxesLoss before income taxes(15,208)(16,594)Loss before income taxes(8,200)(16,601)(35,146)(47,543)
Income taxesIncome taxes216 100 Income taxes340 246 770 488 
Net lossNet loss(15,424)(16,694)Net loss(8,540)(16,847)(35,916)(48,031)
Other comprehensive loss:Other comprehensive loss:Other comprehensive loss:
Foreign currency translation gain105 — 
Foreign currency translation lossForeign currency translation loss(181)(148)(4)(106)
Unrealized gain (loss) on investmentsUnrealized gain (loss) on investments13 (143)Unrealized gain (loss) on investments122 (14)134 (202)
Total comprehensive lossTotal comprehensive loss$(15,306)$(16,837)Total comprehensive loss$(8,599)$(17,009)$(35,786)$(48,339)
Net loss per share, basic and dilutedNet loss per share, basic and diluted$(0.53)$(0.61)Net loss per share, basic and diluted$(0.29)$(0.60)$(1.23)$(1.73)
Weighted average common shares used to
compute net loss per share, basic and diluted
Weighted average common shares used to
compute net loss per share, basic and diluted
29,089,950 27,517,268 Weighted average common shares used to
compute net loss per share, basic and diluted
29,365,968 28,226,345 29,229,626 27,782,093 

The accompanying notes are an integral part of these unaudited consolidated financial statements.
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Inspire Medical Systems, Inc.
Consolidated Statements of Stockholders' Equity (unaudited)
(in thousands, except share amounts)

Three Months Ended March 31, 2023Nine Months Ended September 30, 2023
Common StockCommon Stock
SharesAmountAdditional
Paid-In
Capital
Accumulated
Other
Comprehensive
(Loss) Income
Accumulated
Deficit
Total
Stockholders'
Equity
SharesAmountAdditional
Paid-In
Capital
Accumulated
Other
Comprehensive
(Loss) Income
Accumulated
Deficit
Total
Stockholders'
Equity
Balance at December 31, 2022Balance at December 31, 202229,008,368 $29 $820,335 $(86)$(324,270)$496,008 Balance at December 31, 202229,008,368 $29 $820,335 $(86)$(324,270)$496,008 
Stock options exercisedStock options exercised142,167 — 7,377 — — 7,377 Stock options exercised142,167 — 7,377 — — 7,377 
Vesting of restricted stock unitsVesting of restricted stock units18,852 — — — — — Vesting of restricted stock units18,852 — — — — — 
Withholding taxes on net share settlement of restricted stock unitsWithholding taxes on net share settlement of restricted stock units(6,750)— (1,746)— — (1,746)Withholding taxes on net share settlement of restricted stock units(6,750)— (1,746)— — (1,746)
Issuance of common stockIssuance of common stock364 — 90 — — 90 Issuance of common stock364 — 90 — — 90 
Stock-based compensation expenseStock-based compensation expense— — 18,225 — — 18,225 Stock-based compensation expense— — 18,225 — — 18,225 
Other comprehensive incomeOther comprehensive income— — — 118 — 118 Other comprehensive income— — — 118 — 118 
Net lossNet loss— — — — (15,424)(15,424)Net loss— — — — (15,424)(15,424)
Balance at March 31, 2023Balance at March 31, 202329,163,001 $29 $844,281 $32 $(339,694)$504,648 Balance at March 31, 202329,163,001 29 844,281 32 (339,694)504,648 
Stock options exercisedStock options exercised143,693 — 13,113 — — 13,113 
Vesting of restricted stock unitsVesting of restricted stock units9,349 — — — — — 
Withholding taxes on net share settlement of restricted stock unitsWithholding taxes on net share settlement of restricted stock units(3,237)— (971)— — (971)
Issuance of common stockIssuance of common stock390 — 91 — — 91 
Issuance of common stock for employee stock purchase planIssuance of common stock for employee stock purchase plan12,983 — 2,792 — — 2,792 
Stock-based compensation expenseStock-based compensation expense— — 21,567 — — 21,567 
Other comprehensive incomeOther comprehensive income— — — 71 — 71 
Net lossNet loss— — — — (11,952)(11,952)
Balance at June 30, 2023Balance at June 30, 202329,326,179 29 880,873 103 (351,646)529,359 
Stock options exercisedStock options exercised72,632 — 4,016 — — 4,016 
Vesting of restricted stock unitsVesting of restricted stock units6,272 — — — — — 
Issuance of common stockIssuance of common stock279 — 91 — — 91 
Withholding taxes on net share settlement of restricted stock unitsWithholding taxes on net share settlement of restricted stock units(2,173)— (516)— — (516)
Stock-based compensation expenseStock-based compensation expense— — 19,829 — — 19,829 
Other comprehensive lossOther comprehensive loss— — — (59)— (59)
Net lossNet loss— — — — (8,540)(8,540)
Balance at September 30, 2023Balance at September 30, 202329,403,189 $29 $904,293 $44 $(360,186)$544,180 

The accompanying notes are an integral part of these unaudited consolidated financial statements.


Three Months Ended March 31, 2022
Common Stock
SharesAmountAdditional
Paid-In
Capital
Accumulated
Other
Comprehensive
Loss
Accumulated
Deficit
Total
Stockholders'
Equity
Balance at December 31, 202127,416,106 $27 $508,465 $(55)$(279,389)$229,048 
Stock options exercised151,186 3,086 — — 3,087 
Vesting of restricted stock units569 — — — — — 
Withholding taxes on net share settlement of restricted stock units(205)— (43)— — (43)
Issuance of common stock348 — 79 — — 79 
Stock-based compensation expense— — 9,721 — — 9,721 
Other comprehensive loss— — — (143)— (143)
Net loss— — — — (16,694)(16,694)
Balance at March 31, 202227,568,004 $28 $521,308 $(198)$(296,083)$225,055 
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Inspire Medical Systems, Inc.
Consolidated Statements of Stockholders' Equity (unaudited)
(in thousands, except share amounts)

Nine Months Ended September 30, 2022
Common Stock
SharesAmountAdditional
Paid-In
Capital
Accumulated
Other
Comprehensive
Loss
Accumulated
Deficit
Total
Stockholders'
Equity
Balance at December 31, 202127,416,106 $27 $508,465 $(55)$(279,389)$229,048 
Stock options exercised151,186 3,086 — — 3,087 
Vesting of restricted stock units569 — — — — — 
Withholding taxes on net share settlement of restricted stock units(205)— (43)— — (43)
Issuance of common stock348 — 79 — — 79 
Stock-based compensation expense— — 9,721 — — 9,721 
Other comprehensive loss— — — (143)— (143)
Net loss— — — — (16,694)(16,694)
Balance at March 31, 202227,568,004 28 521,308 (198)(296,083)225,055 
Stock options exercised52,383 — 1,549 — — 1,549 
Issuance of common stock314 — 80 — — 80 
Issuance of common stock for employee stock purchase plan13,743 — 2,134 — — 2,134 
Stock-based compensation expense— — 12,659 — — 12,659 
Other comprehensive loss— — — (3)— (3)
Net loss— — — — (14,490)(14,490)
Balance at June 30, 202227,634,444 28 537,730 (201)(310,573)226,984 
Stock options exercised35,826 — 1,760 — — 1,760 
Issuance of common stock410 — 79 — — 79 
Sale of common stock from follow-on public offering, net of offering expenses1,150,000 243,800 — — 243,801 
Stock-based compensation expense— — 14,589 — — 14,589 
Other comprehensive loss— — — (162)— (162)
Net loss— — — — (16,847)(16,847)
Balance at September 30, 202228,820,680 $29 $797,958 $(363)$(327,420)$470,204 

The accompanying notes are an integral part of these unaudited consolidated financial statements.
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Inspire Medical Systems, Inc.
Consolidated Statements of Cash Flows (unaudited)
(in thousands)
Three Months Ended
March 31,
Nine Months Ended
September 30,
20232022 20232022
Operating activitiesOperating activities  Operating activities  
Net lossNet loss$(15,424)$(16,694)Net loss$(35,916)$(48,031)
Adjustments to reconcile net loss:Adjustments to reconcile net loss:  Adjustments to reconcile net loss:  
Depreciation and amortizationDepreciation and amortization593 359 Depreciation and amortization2,029 1,289 
Non-cash lease expenseNon-cash lease expense265 260 Non-cash lease expense986 778 
Stock-based compensation expenseStock-based compensation expense18,225 9,721 Stock-based compensation expense59,621 36,969 
Non-cash stock issuance for services renderedNon-cash stock issuance for services rendered90 79 Non-cash stock issuance for services rendered272 238 
Other, netOther, net(1)61 Other, net1,271 (553)
Changes in operating assets and liabilities:Changes in operating assets and liabilities:  Changes in operating assets and liabilities:  
Accounts receivableAccounts receivable1,489 (382)Accounts receivable(11,588)(14,395)
InventoriesInventories(3,777)(4,967)Inventories(14,228)2,086 
Prepaid expenses and other current assetsPrepaid expenses and other current assets(579)216 Prepaid expenses and other current assets(2,947)(1,712)
Accounts payableAccounts payable8,390 5,520 Accounts payable11,075 8,601 
Accrued expenses and other liabilitiesAccrued expenses and other liabilities(10,615)(6,921)Accrued expenses and other liabilities(3,189)7,030 
Net cash used in operating activities(1,344)(12,748)
Net cash provided by (used in) operating activitiesNet cash provided by (used in) operating activities7,386 (7,700)
Investing activitiesInvesting activities  Investing activities  
Purchases of property and equipmentPurchases of property and equipment(3,753)(1,215)Purchases of property and equipment(15,596)(6,146)
Purchases of investmentsPurchases of investments(137,253)— 
Proceeds from sales or maturities of investmentsProceeds from sales or maturities of investments10,000 — 
Purchases of strategic investmentsPurchases of strategic investments— (250)Purchases of strategic investments(250)(10,500)
Net cash used in investing activitiesNet cash used in investing activities(3,753)(1,465)Net cash used in investing activities(143,099)(16,646)
Financing activitiesFinancing activities  Financing activities  
Payments on long-term debt obligationPayments on long-term debt obligation— (24,500)
Proceeds from sale of common stockProceeds from sale of common stock— 243,801 
Proceeds from the exercise of stock optionsProceeds from the exercise of stock options7,377 3,087 Proceeds from the exercise of stock options24,506 6,396 
Taxes paid on net share settlement of restricted stock unitsTaxes paid on net share settlement of restricted stock units(1,746)(43)Taxes paid on net share settlement of restricted stock units(3,233)(43)
Proceeds from issuance of common stock from employee stock purchase planProceeds from issuance of common stock from employee stock purchase plan2,792 2,134 
Net cash provided by financing activitiesNet cash provided by financing activities5,631 3,044 Net cash provided by financing activities24,065 227,788 
Effect of exchange rate on cashEffect of exchange rate on cash(7)Effect of exchange rate on cash(47)(101)
Increase (decrease) in cash and cash equivalents540 (11,176)
(Decrease) increase in cash and cash equivalents(Decrease) increase in cash and cash equivalents(111,695)203,341 
Cash and cash equivalents at beginning of periodCash and cash equivalents at beginning of period441,592 214,467 Cash and cash equivalents at beginning of period441,592 214,467 
Cash and cash equivalents at end of periodCash and cash equivalents at end of period$442,132 $203,291 Cash and cash equivalents at end of period$329,897 $417,808 
Supplemental cash flow informationSupplemental cash flow information  Supplemental cash flow information  
Cash paid for interestCash paid for interest$— $466 Cash paid for interest$— $2,321 
Property and equipment included in accounts payable and accrued expensesProperty and equipment included in accounts payable and accrued expenses2,577 284 Property and equipment included in accounts payable and accrued expenses3,499 1,332 

The accompanying notes are an integral part of these unaudited consolidated financial statements.
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Inspire Medical Systems, Inc.
Notes to Consolidated Financial Statements (Unaudited) 
(Table amounts in thousands, except share and per share amounts)

1. Organization
Description of Business
Inspire Medical Systems, Inc. is 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 United States ("U.S.") Food and Drug Administration ("FDA") approved neurostimulation technology that provides a safe and effective treatment for moderate to severe OSA. 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 and was formally added to the Japan National Health Insurance Payment Listing in 2021. In 2020, the Australian Therapeutic Goods Administration approved Inspire therapy to treat moderate to severe OSA, and we are currently seeking reimbursement coverage in Australia.

2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) for interim financial reporting and as required by the rules and regulations of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with GAAP, we must make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, the results of operations for the interim periods are not necessarily indicative of the operating results for the full fiscal year or any future periods. All intercompany accounts and transactions have been eliminated in consolidation.
For a complete discussion of our significant accounting policies and other information, the unaudited consolidated financial statements and notes thereto should be read in conjunction with the audited financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022.
Follow-On Public Offering
On August 15, 2022, we completed a follow-on offering that included our offer and sale of 1,150,000 shares of common stock at a public offering price of $215.00 per share. We received net proceeds of $243.8 million after deducting underwriting discounts, commissions, and offering expenses.
Cash and Cash Equivalents
We consider all highly liquid securities, readily convertible to cash, that have original maturities of 90 days or less from the date of purchase to be cash equivalents. The carrying amount reported in the consolidated balance sheets for cashCash is carried at cost, which approximates fair value, and cash equivalents, which consist of money market funds and corporate debt securities, are stated at fair value.
Foreign Currency
Our functional and reporting currency is the U.S. dollar. Our subsidiary has asubsidiaries have functional currency in Euro.Euro and Yen. The consolidated financial statements are translated to U.S. dollars. Non-monetary assets and liabilities denominated in foreign currencies are translated at rates of exchange in effect at the date of the transaction. Monetary assets and liabilities denominated in foreign currencies are translated using the exchange rate prevailing at the balance sheet date. Sales and expenses denominated in foreign currencies are translated at exchange rates in effect on the date
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
in effect on the date of the transaction. Foreign currency transaction gains and losses and the impacts of foreign currency remeasurement are recognized in other (income) expense, net in the consolidated statements of operations and comprehensive loss. For both of the three-month periods ended March 31,September 30, 2023 and 2022, we recognized $0$0.2 million and $0.1 million of gains, net, respectively. For both of the nine-month periods ended September 30, 2023 and 2022, we recognized $0.3 million of gains, net. Any unrealized gains and losses due to translation adjustments are included in accumulated other comprehensive income (loss) within stockholders' equity in the consolidated balance sheets. We had $0.1 million of unrecognized gain in our accumulated other comprehensive income (loss) balance as of both March 31,September 30, 2023 and December 31, 2022.
Investments
At both March 31,Our investments are classified as available-for-sale and consisted of the following:
September 30, 2023
AmortizedUnrealized GrossAggregate
CostGainsLossesFair Value
Short-Term:
Commercial paper$2,907 $— $(1)$2,906 
Corporate debt securities29,182 (25)29,158 
Certificates of deposit2,953 — — 2,953 
U.S. treasury debt securities99,317 (18)99,300 
Short-term investments$134,359 $$(44)$134,317 
Long-Term:
Corporate debt securities$1,930 $— $(1)$1,929 
Asset-backed securities1,031 — 1,032 
Long-term investments$2,961 $$(1)$2,961 

December 31, 2022
AmortizedUnrealized GrossAggregate
CostGainsLossesFair Value
Short-Term:
U.S. treasury debt securities$9,998 $— $(177)$9,821 
Short-term investments$9,998 $— $(177)$9,821 
As of September 30, 2023 and December 31, 2022, ourwe had no investments consistedwith a contractual maturity of U.S. government securities. greater than three years.
Investments are classified as available-for-sale and are reported at their estimated fair market values which are based on quoted, active or inactive market prices when available. Any unrealized gains and losses due to interest rate fluctuations and other external factors are reported as a separate component of accumulated other comprehensive loss within stockholders' equity. We had $0.1$0.0 million and $0.2 million of unrecognized loss in our accumulated other comprehensive income (loss) balance at March 31,September 30, 2023 and December 31, 2022, respectively. Any realized gains and losses are calculated on the specific identification method and reported net in other (income) expense, net in the consolidated statements of operations and comprehensive loss. For both of the three and nine months ended March 31,September 30, 2023 and 2022, we recognized $0 of realized gains,losses, net.
We reassess our estimatedEach reporting period, we evaluate whether declines in fair value below carrying value are due to expected credit losses, on investments each reporting period. U.S. government securitiesas well as our ability and cash equivalentsintent to hold the investment until a forecasted recovery occurs. Expected credit
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
losses, not to exceed the amount of the unrealized loss, are under a "zero-loss exception" for credit losses, meaning no credit loss risk calculation is necessary on those instruments due to the exceptionally low rate of default, which continues to decreaserecorded as the securities approach maturity, which for us is no longer than one year. We record changesan allowance through other expense, net in the allowance for credit losses for available-for-sale debt securities with a corresponding adjustment in credit loss expense on the consolidated statementstatements of operations and comprehensive loss. No reversal of a previously recorded allowance for credit losses may be made to an amount below zero. The total allowance for credit losses was $0 at both March 31,September 30, 2023 and December 31, 2022.
Fair Value of Financial Instruments
We measure certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents and investments. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. A three-tier fair value hierarchy is established as a basis for considering such assumptions and for inputs used in the valuation methodologies in measuring fair value:
Level 1: Observable inputs, such as quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level 2: Inputs other thaninclude quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, and liabilitiesinputs (other than quoted prices) that are observable for the asset or liability, either directly or indirectly for substantially the full term of the asset or liability.indirectly.
Level 3: Unobservable inputs that are supported by little or no market activities, which would require us to develop our own assumptions.
We useclassify instruments within Level 1 if quoted prices are available in active markets for identical assets, which include our money market funds and U.S. treasury securities. We classify instruments in Level 2 if the methodsinstruments are valued using observable inputs to quoted market prices, benchmark yields, reported trades, broker/dealer quotes or an income approach, such as a discounted cash flow pricing model that calculates values from observable inputs such as quoted interest rates, yield curves and assumptions described belowother observable market information. These instruments include our commercial paper, certificates of deposit, corporate debt securities and asset-backed securities. The available-for-sale securities are held by a custodian who obtains investment prices from a third-party pricing provider that uses standard inputs (observable in determiningthe market) to models which vary by asset class.
The following tables set forth by level within the fair value hierarchy our assets that are measured on a recurring basis and reported at fair value as of our financial instruments.
Money market funds: Fair values of money market fundsSeptember 30, 2023 and December 31, 2022. Assets are classified in their entirety based on quoted market prices in active markets. These are included as Level 1 measurements in the tables below.lowest level of input that is significant to the fair value measurement.
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
U.S. government securities: Consists of U.S. government Treasury bills with original maturities of less than one year and are based on quoted prices in active markets. These are included as Level 1 measurements in the tables below.
The following tables set forth by level within the fair value hierarchy our assets that are measured on a recurring basis and reported at fair value as of March 31, 2023 and December 31, 2022. Assets are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.
Fair Value Measurements as ofFair Value Measurements as of
March 31, 2023September 30, 2023
Estimated
Fair Value
Level 1Level 2Level 3Estimated
Fair Value
Level 1Level 2Level 3
Cash equivalents:Cash equivalents:Cash equivalents:
Money market fundsMoney market funds$395,037 $395,037 $— $— Money market funds$284,353 $284,353 $— $— 
Corporate debt securitiesCorporate debt securities2,923 — 2,923 — 
Total cash equivalentsTotal cash equivalents395,037 395,037 — — Total cash equivalents287,276 284,353 2,923 — 
Investments:Investments:Investments:
Commercial paperCommercial paper2,906 — 2,906 — 
Corporate debt securitiesCorporate debt securities31,087 — 31,087 — 
Certificates of depositCertificates of deposit2,953 — 2,953 — 
Asset-backed securitiesAsset-backed securities1,032 — 1,032 — 
U.S. government securitiesU.S. government securities9,927 9,927 — — U.S. government securities99,300 99,300 — — 
Total investmentsTotal investments9,927 9,927 — — Total investments137,278 99,300 37,978 — 
Total cash equivalents and investmentsTotal cash equivalents and investments$404,964 $404,964 $— $— Total cash equivalents and investments$424,554 $383,653 $40,901 $— 
Fair Value Measurements as of
December 31, 2022
Estimated
Fair Value
Level 1Level 2Level 3
Cash equivalents:
Money market funds$390,846 $390,846 $— $— 
Total cash equivalents390,846 390,846 — — 
Investments:
U.S. government securities9,821 9,821 — — 
Total investments9,821 9,821 — — 
Total cash equivalents and investments$400,667 $400,667 $— $— 
There were no transfers between levels during the periods ended March 31,September 30, 2023 and December 31, 2022.
Concentration of Credit Risk
Financial instruments, which potentially subject us to concentrations of credit risk, consist principally of cash equivalents, investments, and accounts receivable. We maintain the majority of our cash and cash equivalents in accounts with major U.S. and multi-national financial institutions, and our deposits at certain of these institutions exceed insured limits. Market conditions can impact the viability of these institutions. In the event of failure of any of the financial institutions where we maintain our cash and cash equivalents, there can be no assurance that we will be able to access uninsured funds in a timely manner or at all.
Our investment policy limits investments to certain types of debt securities issued by the U.S. government and its agencies, corporations with investment-grade credit ratings, or commercial paper and money market funds issued by the highest quality financial and non-financial companies. We place restrictions on maturities and concentration by type and issuer. We are exposed to credit risk in the event of a default by the issuers of these securities to the extent recorded on the consolidated balance sheets. However, as of March 31,September 30, 2023 and December 31, 2022, we limited our credit risk associated with cash equivalents by placing investments with banks we believe are highly creditworthy.
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
We believe that the credit risk in our accounts receivable is mitigated by our credit evaluation process, relatively short collection terms, and dispersion of our customer base. We generally do not require collateral, and losses on accounts receivable have historically not been significant.
Accounts Receivable and Allowance for Expected Credit Losses
Trade accounts receivable are recorded at the invoiced amount and do not bear interest. Customer credit terms are established prior to shipment with the general standard being net 30 days. Collateral or any other security to support payment of these receivables generally is not required.
Each reporting period, we estimate the credit loss related to accounts receivable based on a migration analysis of accounts grouped by individual receivables delinquency status, and apply our historic loss rate adjusted for management's assumption of future market conditions. Any change in the allowance from new receivables acquired, or changes due to credit deterioration on previously existing receivables, is recorded in selling, general and administrative expenses. Write-offs of receivables considered uncollectible are deducted from the allowance. Specific accounts receivable are written-off once a determination is made that the amount is uncollectible. The write-off is recorded in the period in which the account receivable is deemed uncollectible. Recoveries are recognized when received and as a direct credit to earnings or as a reduction to the allowance for credit losses (which would indirectly reduce the loss by decreasing bad debt expense).
Inventories
Inventories are valued at the lower of cost or net realizable value, computed on a first-in, first-out basis and consisted of the following:
March 31, 2023December 31, 2022September 30, 2023December 31, 2022
Raw materialsRaw materials$5,143 $5,645 Raw materials$4,381 $5,645 
Finished goodsFinished goods10,520 6,241 Finished goods21,734 6,241 
Total inventories, net of reservesTotal inventories, net of reserves$15,663 $11,886 Total inventories, net of reserves$26,115 $11,886 
We expense prelaunch inventory as research and development expense in the period incurred unless objective and persuasive evidence exists that regulatory approval and subsequent commercialization of a product candidate is probable and where we also expect the future economic benefit from the sales of the product candidate to be realized. At both September 30, 2023 and December 31, 2022, there was $0 included in inventory related to prelaunch inventory.
We regularly review inventory quantities on-hand for excess and obsolete inventory and, when circumstances indicate, incur charges to write down inventories to their net realizable value. The determination of a reserve for excess and obsolete inventory involves management exercising judgment to determine the required reserve, considering future demand, product life cycles, introduction of new products and current market conditions. The reserve for excess and obsolete inventory was $3.5 million and $2.7 million as of both March 31,September 30, 2023 and December 31, 2022.2022, respectively.
Property and Equipment
Property and equipment are stated at cost, less accumulated depreciation and amortization and consisted of the following:
March 31, 2023December 31, 2022
Computer equipment and software$1,729 $1,729 
Manufacturing equipment5,974 5,974 
Other equipment600 535 
Leasehold improvements2,086 2,064 
Construction in process16,034 11,857 
Property and equipment, cost26,423 22,159 
Less: accumulated depreciation and amortization(5,503)(4,910)
Property and equipment, net$20,920 $17,249 
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
September 30, 2023December 31, 2022
Computer equipment and software$2,152 $1,729 
Manufacturing equipment7,105 5,974 
Other equipment1,847 535 
Leasehold improvements2,136 2,064 
Construction in process25,948 11,857 
Property and equipment, cost39,188 22,159 
Less: accumulated depreciation and amortization(6,939)(4,910)
Property and equipment, net$32,249 $17,249 
Depreciation is determined using the straight-line method over the estimated useful lives of the respective assets, generally three to five years. Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or the term of the lease. Depreciation and amortization expense was $0.6$0.8 million and $0.4$0.5 million for the three months ended March 31,September 30, 2023 and 2022, respectively, and $2.0 million and $1.3 million for the nine months ended September 30, 2023 and 2022, respectively.
Strategic Investments
For equity securities without readily determinable fair values, we have elected the measurement alternative under which we measure these investments at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer. These securities are presented within other non-current assets on the consolidated balance sheets. The balance of equity securities without readily determinable fair values was $10.8 million and $10.5 million as of both March 31,September 30, 2023 and December 31, 2022.2022, respectively. There were no adjustments to the carrying amount during either of the threenine months ended March 31,September 30, 2023 or 2022.
Impairment of Long-lived Assets
Long-lived assets consist primarily of property and equipment and operating lease right-of-use asset and are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If circumstances require that an asset be tested for possible impairment, we compare the undiscounted cash flows expected to be generated by the asset to the carrying amount of the asset. If the carrying amount of the asset is not recoverable on an undiscounted cash flow basis, we determine the fair value of the asset and recognize an impairment loss to the extent the carrying amount of the asset exceeds its fair value. We determine fair value using the income approach based on the present value of expected future cash flows or other appropriate measures of estimated fair value. Our cash flow assumptions consider historical and forecasted revenue and operating costs and other relevant factors. We did not record any impairment charges on long-lived assets during either of the threenine months ended March 31,September 30, 2023 or 2022.
Accrued Expenses
Accrued expenses consisted of the following:
March 31, 2023December 31, 2022
Payroll related$19,258 $30,398 
Product warranty liability741 920 
Operating lease liabilities, current portion1,367 1,336 
Other accrued expenses2,024 1,685 
Total accrued expenses$23,390 $34,339 
The following table shows the changes in our estimated product warranty liability accrual, included in accrued liabilities:
Three Months Ended
March 31, 2023
20232022
Balance at beginning of period$920 $468 
Provisions for warranty132 11 
Settlements of warranty claims(311)(41)
Balance at the end of the period$741 $438 
September 30, 2023December 31, 2022
Payroll related$26,218 $30,398 
Product warranty liability805 920 
Operating lease liabilities, current portion— 1,336 
Other accrued expenses2,941 1,685 
Total accrued expenses$29,964 $34,339 
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
The following table shows the changes in our estimated product warranty liability accrual, included in accrued liabilities:
Three Months Ended September 30,Nine Months Ended September 30,
2023202220232022
Balance at beginning of period$760 $488 $920 $468 
Provisions for warranty174 201 457 322 
Settlements of warranty claims(129)(61)(572)(162)
Balance at the end of the period$805 $628 $805 $628 
Revenue Recognition
We derive our revenue from sales of our products in the U.S. and internationally. Customers are primarily comprised of hospitals and ambulatory surgery centers, with distributors being used in certain international locations where we do not have a direct commercial presence.
Revenues from product sales are recognized when the customer obtains control of the product, which occurs at a point in time, either upon shipment of the product or receipt of the product, depending on shipment terms. Our standard shipping terms are free on board shipping point, unless the customer requests that control and title to the inventory transfer upon delivery. In those cases where shipping and handling costs are billed to customers, we classify the amounts billed as a component of cost of goods sold.
Revenue is measured as the amount of consideration we expect to receive, adjusted for any applicable estimates of variable consideration and other factors affecting the transaction price, which is based on the invoiced price, in exchange for transferring products. All revenue is recognized when we satisfy our performance obligations under the contract. The majority of our contracts have a single performance obligation and are short term in nature.
Sales taxes and value added taxes in foreign jurisdictions that are collected from customers and remitted to governmental authorities are accounted for on a net basis and therefore are excluded from net sales. Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are accounted for as a fulfillment cost and are included in cost of goods sold.
Variable consideration related to certain customer sales incentives is estimated based on the amounts expected to be paid based on the agreement with the customer using probability assessments.
We offer customers a limited right of return for our product in case of non-conformity or performance issues. We estimate the amount of our product sales that may be returned by our customers based on historical sales and returns. As our historical product returns to date have been immaterial, we have not recorded a reduction in revenue related to variable consideration for product returns.
See Note 98 for disaggregated revenue by geographic area.
Cost of Goods Sold
Cost of goods sold consists primarily of acquisition costs for the components of the Inspire system, overhead costs, scrap and inventory obsolescence, warranty replacement costs, as well as distribution-related expenses such as logistics and shipping costs, net of shipping costs charged to customers. The overhead costs include the cost of material procurement, depreciation expense for production equipment, and operations supervision and management personnel, including employee compensation, stock-based compensation, supplies, and travel.
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
Research and Development
Research and development expenses consist primarily of product development, clinical and regulatory affairs, quality assurance, consulting services, and other costs associated with products and technologies in development. These expenses include employee compensation, including stock-based compensation, supplies, materials, prelaunch inventory, consulting, and travel expenses related to research and development programs. Clinical expenses include clinical study design, clinical site reimbursement, data management, travel expenses, and the cost of manufacturing products for clinical studies.
We expense prelaunch inventory as research and development expense in the period incurred unless objective and persuasive evidence exists that regulatory approval and subsequent commercialization of a product candidate is probable and where we also expect the future economic benefit from the sales of the product candidate to be realized. Prelaunch inventory expenses were $1.7 million and $0.0 million during the three months ended September 30, 2023 and 2022, respectively and $4.7 million and $0.0 million during the nine months ended September 30, 2023 and 2022, respectively.
Stock-Based Compensation
We maintain an equity incentive plan to provide long-term incentives for eligible employees, consultants, and members of the board of directors. The plan allows for the issuance of restricted stock units ("RSUs"), performance stock units ("PSUs"), and non-statutory and incentive stock options to employees, and RSUs, PSUs, and non-
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
statutorynon-statutory stock options to consultants and directors. We also offer an employee stock purchase plan ("ESPP") which allows participating employees to purchase shares of our common stock at a discount through payroll deductions.
We recognize equity-based compensation expense for awards of equity instruments based on the grant date fair value of those awards as expense in the consolidated statements of operations and comprehensive loss. We estimate the fair value of stock options using the Black-Scholes option pricing model and the fair value of RSUs and PSUs is equal to the closing price of our common stock on the grant date. The fair value of each purchase under the employee stock purchase plan is estimated at the beginning of the offering period using the Black-Scholes option pricing model.
Stock-based compensation expense is recognized on a straight-line basis over the vesting term for stock options and RSUs, and over the vesting and performance period based on the probability of achieving the performance objectives for PSUs. We account for award forfeitures as they occur.
Advertising Expenses
We expense the costs of advertising, including promotional expenses, as incurred. Advertising expenses were $23.6$25.5 million and $15.5$20.1 million during the three months ended March 31,September 30, 2023 and 2022, respectively, and $74.3 million and $53.6 million during the nine months ended September 30, 2023 and 2022, respectively.
Leases
Operating leases are included in operating lease right-of-use ("ROU") asset, accrued expenses, and operating lease liability – non-current portion in our consolidated balance sheets. ROU assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the present value of lease payments, we use our incremental borrowing rate based on the information available at the lease commencement date as the rate implicit in the lease is not readily determinable. The determination of our incremental borrowing rate requires management judgment based on information available at lease commencement. The operating lease ROU assets also include adjustments for prepayments, accrued lease payments, and exclude lease incentives. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise such options. Operating lease cost is recognized on a straight-line basis over the expected lease term. Lease
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
agreements that include lease and non-lease components are accounted for as a single lease component. Lease agreements with a noncancelable term of less than 12 months are not recorded on our consolidated balance sheets.
Income Taxes
We account for income taxes using the liability method. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates that will be in effect when the differences are expected to reverse. Valuation allowances against deferred tax assets are established, when necessary, to reduce deferred tax assets to the amounts expected to be realized. As we have historically incurred operating losses, we have recorded a full valuation allowance against our net deferred tax assets, and there is no provision for income taxes other than minimal state and foreign taxes, which includes a foreign tax provision relating to uncertain tax positions. Our policy is to record interest and penalties expense related to uncertain tax positions as other expense in the consolidated statements of operations and comprehensive loss.
Comprehensive LossIncome (Loss)
Comprehensive income (loss) consists of net loss and changes in unrealized gains and losses due to interest rate fluctuations and other external factors on investments classified as available-for-sale, and foreign currency translation adjustments. Accumulated other comprehensive income (loss) is presented in the accompanying consolidated balance sheets as a component of stockholders' equity.
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
Loss Per Share
Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock and dilutive potential shares of common stock outstanding during the period. Because we have reported a net loss for all periods presented, diluted net loss per share is the same as basic net loss per share as all potentially dilutive shares consisting of outstanding stock options, unvested RSUs and PSUs, and shares issuable under our employee stock purchase plan were antidilutive in those periods.
Recent Accounting Pronouncements
We have reviewed and considered all recent accounting pronouncements that have not yet been adopted and believe there are none that could potentially have a material impact on our business practices, financial condition, results of operations, or disclosures.

3. Investments
Our investments are classified as available-for-sale and consist of the following:
March 31, 2023
AmortizedUnrealized GrossAggregate
CostGainsLossesFair Value
Short-Term:
U.S. government securities$9,999 $— $(72)$9,927 
Short-term investments$9,999 $— $(72)$9,927 
December 31, 2022
AmortizedUnrealized GrossAggregate
CostGainsLossesFair Value
Short-Term:
U.S. government securities$9,998 $— $(177)$9,821 
Short-term investments$9,998 $— $(177)$9,821 
As of March 31, 2023 and December 31, 2022, we had no investments with a contractual maturity of greater than one year. Currently, we do not intend to sell the investments and it is not more likely than not that we will be required to sell the investments before recovery of their amortized cost bases, which may be maturity. We do not consider those investments to be other-than-temporarily impaired as of March 31, 2023. At the end of each reporting period, we evaluate potential credit impairment on available-for-sale securities in an unrealized loss position, based on the expected cash flows to be collected and the yield-to-maturity on those securities. Securities with a valuation allowance for expected credit losses and deemed uncollectible are permanently written down, and a reversal out of the valuation allowance occurs.

4. Leases
We lease approximately 70,000 square feet of office space for our corporate headquarters under a non-cancelable operating leases.lease. The corporate office leases expirewere amended in May 2023 to increase the total space leased to approximately 106,000 square feet and to extend the noncancellable lease term through May 31, 2028 with2035, resulting in a non-cash increase in the associated right-of-use asset and lease liability of $15.1 million. We entered into an additional warehouse and office space lease for our corporate headquarters under a non-cancelable operating lease in August 2023. This space includes approximately 22,000 square feet and a noncancellable lease term through May 31, 2035, resulting in an associated right-of-use asset and lease liability of $2.3 million. Each lease includes options to renew for oneup to two additional periodperiods of five years each at the then-prevailing market rate.rates. The exercises of the lease renewal options are at our sole discretion and were not included in the lease term for the calculation of the ROU assets and lease liabilities whenas of the leases commencedlease modification date as they were not reasonably certain of exercise.
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
In addition to base rent in these leases, we also pay our proportionate share of the operating expenses, as defined in the leases. These payments are made monthly and adjusted annually to reflect actual charges incurred for operating expenses, such as common area maintenance, taxes, and insurance.
The following table presents the lease balances within the consolidated balance sheets:
March 31, 2023December 31, 2022
Right-of-use assets:
Operating lease right-of-use assets$6,614 $6,880 
Operating lease liabilities:
Accrued expenses1,367 1,336 
Operating lease liabilities, non-current portion7,185 7,536 
Total operating lease liabilities$8,552 $8,872 
September 30, 2023December 31, 2022
Right-of-use assets:
Operating lease right-of-use assets$23,081 $6,880 
Operating lease liabilities:
Accrued expenses 1,336 
Operating lease liabilities, non-current portion25,173 7,536 
Total operating lease liabilities$25,173 $8,872 
Maturities of our lease liability for our operating lease are as follows as of September 30, 2023:
2023 (remaining)$633 
2024(3,582)
20253,056 
20263,313 
20273,416 
Thereafter28,887 
Total undiscounted lease payments35,723 
Less: imputed interest(10,550)
Present value of lease liability$25,173 
As of March 31,September 30, 2023, the remaining lease term was 5.2terms were 11.7 years and the weighted average discount rate was 5.3%4.9%. The operating cash outflows from our operating leases were $0.4$0.6 million and $0.1$0.2 million for the three-month periods ended March 31,September 30, 2023 and 2022, respectively, and $1.5 million and $0.3 million for the nine-month periods ended September 30, 2023 and 2022, respectively.

5.4. Long-Term Debt
In March 2019 we amended our $24.5 million term loan and security agreement, which we refer to as our former credit facility. The debt was interest only until April 1, 2022 and was scheduled to mature on March 1, 2024. The basic interest rate was the 30-day U.S. LIBOR rate, subject to a floor of 7.60%. In addition to the principal and interest payments, we were required to pay a final payment fee of 3.50% on all amounts outstanding, which was accreted using the effective interest rate method over the term of the credit facility and was to be due at the earlier of maturity or prepayment. Borrowings were prepayable in whole at our option, subject to a prepayment fee of 1.00%.
In August 2022, we prepaid the outstanding principal balance of $19.4 million, the final payment fee of $0.9 million, and the prepayment fee of $0.2 million. As of March 31,September 30, 2023 and December 31, 2022, we had no remaining amounts outstanding under our former credit facility.

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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
5. Employee Retirement Plan
We sponsor a defined contribution employee retirement plan covering all of our full-time employees. The plan allows for eligible employees to defer a portion of their eligible compensation up to the maximum allowed by IRS Regulations. Beginning January 1, 2022, we elected to begin making voluntary matching contributions to the plan. We match 50% of the first 6% of each participating employee's contribution, up to 3% of eligible earnings. Our match contributions are made to funds designated by the participant, none of which are based on Inspire common stock. Discretionary contributions to the plan totaled $1.2$0.8 million and $0.7$0.6 million for the three months ended March 31,September 30, 2023 and 2022, respectively, and $3.0 million and $1.9 million for the nine months ended September 30, 2023 and 2022, respectively.

7.6. Stock-Based Compensation
As of March 31,September 30, 2023, there were 4,455,4274,259,385 shares authorized for issuance under our equity incentive plan, of which 1,646,5431,537,529 shares were available for future awards.
Stock-based compensation expense is recognized on a straight-line basis over the vesting term for stock options and RSUs, and over the performance period based on the probability of achieving the performance objectives for PSUs, and is reduced by actual forfeitures as they occur. If there are any modifications or cancellations of the
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
underlying unvested securities, we may be required to accelerate, increase, or cancel any remaining unearned stock compensation expense. Future stock-based compensation expense and unearned stock-based compensation will increase to the extent that we grant additional stock-based awards.
Stock Options
Options are granted at the exercise price, which is equal to the closing price of our stock on the date of grant. The stock options granted to employees include a four-year service period and 25% vest after the first year of service and the remainder vest in equal installments over the next 36 months of service. The stock options granted to the board of directors vest in one or three equal annual installments, in each case, subject to the director's continuous service through the applicable vesting date. The stock options have a contractual life of ten years.
The fair value per share of options is estimated on the date of grant using the Black-Scholes option pricing model.
Option Value and Assumptions
Three Months EndedNine Months Ended
March 31,September 30,
2023202220232022
Weighted average fair valueWeighted average fair value$151.88$125.75Weighted average fair value$153.59$119.23
Assumptions:Assumptions:Assumptions:
Expected term (years)Expected term (years)6.256.25Expected term (years)6.255.50 - 6.25
Expected volatilityExpected volatility57.2 - 57.4%56.6 - 56.9%Expected volatility56.4 - 57.4%56.2 - 57.0%
Risk-free interest rateRisk-free interest rate3.55 - 4.07%1.75 - 2.40%Risk-free interest rate3.49 - 4.61%1.75 - 4.06%
Expected dividend yieldExpected dividend yield0.0%0.0%Expected dividend yield0.0%0.0%
Expected Term — Due to our limited amount of historical exercise, forfeiture, and expiration activity, we have opted to use the "simplified method" for estimating the expected term of options, whereby the expected term equals the arithmetic average of the vesting terms and the original contractual term of the option. We will continue to analyze our expected term assumption as more historical data becomes available.
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
Expected Volatility — Due to our limited company specific historical and implied volatility data, we have incorporated our historical stock trading volatility with those of a group of similar companies that are publicly traded for the calculation of volatility. When selecting this peer group of public companies on which we have based our expected stock price volatility, we generally selected companies with comparable characteristics, including enterprise value, stages of clinical development, risk profiles, position within the industry, and those with historical share price information sufficient to meet the expected life of the stock-based awards. We will continue to analyze the historical stock price volatility assumption as more historical data for our common stock becomes available.
Risk-Free Interest Rate — The risk-free rate assumption is based on the U.S. government Treasury instruments with maturities similar to the expected term of our stock options.
Expected Dividend Yield — The expected dividend assumption is based on our history of not paying dividends and our expectation that we will not declare dividends for the foreseeable future.
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
Stock Option Activity
OptionsWeighted Average
Exercise Price
Weighted Average
Remaining
Contractual Term
(years)
Aggregate Intrinsic
Value
(in thousands)
OptionsWeighted Average
Exercise Price
Weighted Average
Remaining
Contractual Term
(years)
Aggregate Intrinsic
Value
(in thousands)
Outstanding at December 31, 2022Outstanding at December 31, 20222,660,734 $112.19 6.9$372,068Outstanding at December 31, 20222,660,734 $112.19 6.9$372,068
GrantedGranted314,517 $260.89 Granted409,977 $264.13 
ExercisedExercised(142,167)$52.69 $29,432Exercised(358,492)$68.64 $72,896
Forfeited/expiredForfeited/expired(14,695)$191.61 Forfeited/expired(40,404)$206.10 
Outstanding at March 31, 20232,818,389 $131.38 7.1$299,585
Exercisable at March 31, 20231,670,615 $79.15 6.0$259,222
Outstanding at September 30, 2023Outstanding at September 30, 20232,671,815 $139.93 6.8$196,553
Exercisable at September 30, 2023Exercisable at September 30, 20231,699,560 $90.47 5.7$188,465
The aggregate intrinsic value of options exercised is the difference between the estimated fair market value of our common stock at the date of exercise and the exercise price for those options. The aggregate intrinsic value of outstanding options is the difference between the closing price as of the date outstanding and the exercise price of the underlying stock options. As of March 31,September 30, 2023, the amount of unearned stock-based compensation to be expensed from now through the year 2027 related to unvested employee and non-employee director stock options is $122.8$111.1 million, which we expect to recognize over a weighted average period of 2.62.5 years.
Restricted Stock Units
RSUs are share awards that entitle the holder to receive freely tradable shares of our common stock upon vesting. The RSUs cannot be transferred and the awards are subject to forfeiture if the holder’s employment terminates prior to the release of the vesting restrictions. The RSUs include three- or four-year service periods and vest in equal installments on each anniversary of the date of grant, provided the employee remains continuously employed with the Company. The fair value of the RSUs is equal to the closing price of our common stock on the grant date. A summary of RSUs and related information is as follows:
Restricted Stock UnitsWeighted Average
Grant Date Fair Value
Aggregate Intrinsic Value (in thousands)Restricted Stock UnitsWeighted Average
Grant Date Fair Value
Aggregate Intrinsic Value (in thousands)
Unvested at December 31, 2022Unvested at December 31, 2022124,680 $213.97 $31,404 Unvested at December 31, 2022124,680 $213.97 $31,404 
GrantedGranted76,355 $260.17 Granted112,076 $262.87 
VestedVested(18,852)$229.92 $4,882 Vested(34,473)$211.04 $9,168 
ForfeitedForfeited(2,809)$217.18 Forfeited(8,940)$237.12 
Unvested at March 31, 2023179,374 $231.91 $41,986 
Unvested at September 30, 2023Unvested at September 30, 2023193,343 $241.77 $38,367 
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
The aggregate intrinsic value of unvested RSUs was based on our closing stock price on the last trading day of the period. The aggregate intrinsic value of vested RSUs was based on our closing stock price on the date of vest. As of March 31,September 30, 2023, there was $37.7$37.1 million of unrecognized stock-based compensation expense related to RSUs that is expected to be recognized over a weighted average period of 2.52.0 years.
Performance Stock Units
During each of the quarters ended March 31, 2022 and 2023, we granted PSUs to officers and key employees. The number of PSUs that will ultimately be earned is based on our performance relative to pre-established goals for the three-year periods ending December 31, 2024 and December 31, 2025, respectively. The expense is recorded on a straight-line basis over the requisite service periods based on an estimate of the number of PSUs expected to vest. Management expectations related to the achievement of the performance goals associated with PSU grants isare assessed each reporting period. The number of shares earned at the end of each of the three-year periods will vary
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
based on actual performance, from 0% to 200% of the number of PSUs granted. If the performance conditions are not met or not expected to be met, any compensation expense recognized associated with the grants will be reversed.
A summary of PSUs and related information is as follows:
Performance Stock UnitsWeighted Average
Grant Date Fair Value
Aggregate Intrinsic Value (in thousands)Performance Stock UnitsWeighted Average
Grant Date Fair Value
Aggregate Intrinsic Value (in thousands)
Unvested at December 31, 2022Unvested at December 31, 202277,472 $227.53 $19,514 Unvested at December 31, 202277,472 $227.53 $19,514 
GrantedGranted90,434 $263.16 Granted95,994 $264.59 
ForfeitedForfeited(879)$227.53 Forfeited(2,897)$241.54 
Unvested at March 31, 2023167,027 $246.82 $39,096 
Unvested at September 30, 2023Unvested at September 30, 2023170,569 $248.15 $33,848 
The fair value of the PSUs is equal to the closing price of our common stock on the grant date. The aggregate intrinsic value of unvested PSUs was based on our closing stock price on the last trading day of the period. As of March 31,September 30, 2023, there was $49.6$31.1 million of unrecognized stock-based compensation expense related to outstanding PSUs that is expected to be recognized over a weighted-average period of approximately 2.52.0 years.
Employee Stock Purchase Plan
Employees may participate in our ESPP provided they meet certain eligibility requirements. The purchase price for our common stock under the terms of the ESPP is defined as 85% of the lower of the closing market price per share of our common stock on the first or last trading day of each stock purchase period. There were 1,090,7031,077,720 shares available for future issuance under the ESPP as of March 31,September 30, 2023. The current purchase period under the ESPP began on JanuaryJuly 1, 2023 and ends June 30,December 31, 2023.

8.7. Income Taxes
At both March 31,September 30, 2023 and December 31, 2022, a valuation allowance was recorded against all deferred tax assets due to our cumulative net loss position. We recorded income tax expense of $0.3 million and $0.2 million and $0.1 million infor the three months ended March 31,September 30, 2023 and 2022, respectively, and $0.8 million and $0.5 million for the nine months ended September 30, 2023 and 2022, respectively. The nominal income tax expense reflects minimal state and foreign income tax expense in the threenine months ended March 31,September 30, 2023, and minimal state income tax expense and an accrual for uncertain tax benefitspositions in the three and nine months ended March 31,September 30, 2022.
AsWe filed our 2022 U.S. federal income tax return during the third quarter of December 31, 2022,2023. Considering the provision to return true-ups, our gross federal net operating loss carryforward as of December 31, 2022 was $257.4$274.4 million, which will expire at various dates beginning in 2033.2031. In addition, net operating loss carryforwards for state income tax
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
purposes of $183.3 million that include net operating losses will begin to expire in 2024.2028. We also have gross research and development credit carryforwards of $10.1$9.7 million as of December 31, 2022, which will expire at various dates beginning in 2033.
Utilization of the net operating loss carryforwards and R&D credit carryforwards may be subject to an annual limitation due to the ownership change limitations provided by Section 382 and Section 383 of the Internal Revenue Code of 1986 and similar state provisions. During the three months ended March 31, 2023, we finalized a detailed analysis to determine whether an ownership change has occurred and if a limitation exists. It was determined that December 11, 2018 was the only date that we experienced an ownership change. The study concluded that none of the $126.5 million federal net operating losses and $1.7 million of federal R&D credits that were accumulated on December 11, 2018, will expire unused solely due to the limitations under Section 382 and 383.
Realization of the deferred tax assets is dependent upon the generation of future taxable income, if any, the amount and timing of which are uncertain. Based on available objective evidence and cumulative losses, we believe it is
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Inspire Medical Systems, Inc. 
Notes to Consolidated Financial Statements (unaudited) 
(Table amounts in thousands, except share and per share amounts)
more likely than not that the deferred tax assets are not recognizable and will not be recognizable until we have sufficient book income. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance.
We had $0.1 million of grosstax payable on unrecognized tax benefitspositions as of each of March 31,September 30, 2023 and December 31, 2022.
We file income tax returns in the applicable jurisdictions. The 2019 to 20212022 tax years remain open to examination by the major taxing authorities to which we are subject. We do not expect a significant change to our unrecognized tax benefitspositions over the next 12 months.

9.8. Segment Reporting and Revenue Disaggregation
We operate our business as one operating segment. An operating segment is defined as a component of an enterprise for which separate discrete financial information is available and evaluated regularly by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. Segment information is consistent with how management reviews the business, makes investing and resource allocation decisions and assesses operating performance.
We sell our Inspire system to hospitals and ambulatory surgery centers in the U.S. and in select countries in Europe and Japan through a direct sales organization, and in Japan, Singapore and Hong Kong through distributors. Revenue by geographic region is as follows:
Three Months EndedThree Months EndedNine Months Ended
March 31,September 30,September 30,
202320222023202220232022
United StatesUnited States$124,485 $66,426 United States$147,514 $106,279 $416,748 $260,581 
All other countriesAll other countries3,412 2,956 All other countries5,788 2,909 15,543 9,375 
Total revenueTotal revenue$127,897 $69,382 Total revenue$153,302 $109,188 $432,291 $269,956 
All of our long-lived assets are located in the U.S.

10.9. Loss Per Share
Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock and dilutive potential shares of common stock outstanding during the
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INSPIRE MEDICAL SYSTEMS, INC. 
NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited) 
(Table amounts in thousands, except share and per share amounts)
period. Because we have reported a net loss for all periods presented, diluted net loss per share is the same as basic net loss per share as all of the following potentially dilutive shares were antidilutive in those periods.
The following common stock-based awards were excluded from the computation of diluted net loss per common share for the periods presented because including them would have been anti-dilutive:
March 31,September 30,
2023202220232022
Common stock options outstandingCommon stock options outstanding2,818,389 2,763,215 Common stock options outstanding2,671,815 2,788,306 
Unvested restricted stock unitsUnvested restricted stock units179,374 60,785 Unvested restricted stock units193,343 107,930 
Shares issuable under the ESPPShares issuable under the ESPP5,136 5,435 Shares issuable under the ESPP6,319 5,706 
TotalTotal3,002,899 2,829,435 Total2,871,477 2,901,942 

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Item 2.    Management's Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and the related notes to those statements included elsewhere in this Quarterly Report on Form 10-Q, as well as the audited financial statements and the related notes thereto, and the discussion under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business” sections included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, such as information with respect to our plans and strategy for our business and the impact of the ongoing and global COVID-19 pandemic on our business, financial results and financial conditionmacroeconomic factors on our business, financial results and financial condition includes forward-looking statements that involve risks and uncertainties. As a result of many important factors, including those set forth in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, our actual results could differ materially from the results described in, or implied by, these forward-looking statements.

Overview
We are a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with OSA. Our proprietary Inspire system is the first and only FDA-approved neurostimulation technology that provides a safe and effective treatment for 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. 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. In addition, patients in the U.S., Japan, Singapore, and Hong Kong must have been confirmed to fail or be unable to tolerate positive airway pressure treatments, such as CPAP, and be 18 years of age or older, though there are no similar requirements for patients in Europe.
We sell our Inspire system to hospitals and ambulatory surgery centers ("ASCs") in the U.S. and in select countries in Europe and Japan through a direct sales organization and we sell our Inspire system in Japan, Singapore and Hong Kong through distributors. Our direct sales force engages in sales efforts and promotional activities focused on ENT physicians and sleep centers. In addition, we highlight our compelling clinical data and value proposition to increase awareness and adoption amongst referring physicians. We build upon this top-down approach with strong direct-to-consumer marketing initiatives to create awareness of the benefits of our Inspire system and drive interest through patient empowerment. This outreach helps to educate thousands of patients on our Inspire therapy.
Although our sales and marketing efforts are directed at patients and physicians because they are the primary users of our technology, we consider the hospitals and ASCs where the procedure is performed to be our customers, as they are the purchasing agents of our Inspire system. Our customers are reimbursed the cost required to treat each patient through various third-party payors, such as commercial payors and government agencies. Our Inspire system is currently reimbursed primarily on a per-patient prior authorization basis for patients covered by commercial payors, under Local Coverage Determinations for patients covered by Medicare, and under U.S. government contract for patients who are treated by the Veterans Health Administration. As of May 2,November 7, 2023, we have secured positive coverage policies with many U.S. commercial payors, including virtually all large national commercial insurers, covering approximately 260 million lives in the U.S. In addition, all seven Medicare Administrative Contractors published final policies in 2020 that provide coverage of Inspire therapy when certain coverage criteria are met. Reimbursement in other countries can often be established through a combination of private (commercial insurance) and public funding sources, or at the hospital level through innovation budgets.
In November 2023, the final 2024 Medicare reimbursement payments were announced. The 2024 rate for our hospital customers is $29,617 per implantation of a hypoglossal nerve stimulator, an increase of 1% over the 2023 rate. The ASC reimbursement for 2024 is $24,870 per implantation, a decrease of 1% over the 2023 rate. The 2024 physician payment is $823 for implantation, a 6% decrease over the 2023 payment. The 2024 national average drug-induced sleep endoscopy ("DISE") procedure reimbursement to ASCs increased 714% to $757 per procedure over the 2023 rate, while the reimbursement to hospitals for the DISE procedure increased by 806% to $1,619.
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For the threenine months ended March 31,September 30, 2023, 97.3%96.4% of our revenue was derived in the U.S. and 2.7%3.6% was derived outside of the U.S. No single customer accounted for more than 10% of our revenue during the threenine months ended March 31,September 30, 2023.
We rely on third-party suppliers to manufacture our Inspire system and its components. Many of these suppliers are currently single source suppliers. We have experienced and continue to experience supply disruptions whichthat began
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during the COVID-19 pandemic, but to date we have managed to avoid any significant supply and inventory issues or delay in implant procedures due to those issues. During the third quarter of 2023, we began experiencing an inventory supply issue related to our polyurethane-based stimulation leads, one component of the Inspire system currently used only in the European market. In 2022, the FDA approved our silicone-based stimulation and sensing leads in the U.S., which replaced the polyurethane versions of the leads, and we stopped manufacturing polyurethane leads. We applied for European Union ("EU") Medical Devices Regulation ("MDR") in December 2021, which we expect to obtain in the first quarter of 2024, following delays in the process. In the interim, we received a derogation from the Dutch national competent authority allowing us to place the silicone-based leads on the market until April 1, 2024 or until we receive certification under the EU MDR, whichever occurs first. We are also pursuing derogation in several other EU member states. However, such derogations are granted at the national level only and we cannot be certain that national competent authorities of the other EU member states will grant a derogation similar to the Dutch authority. Until we obtain certification under the EU MDR or these derogations are received, we may only sell our polyurethane-based leads in the EU, where the stimulation lead is in low supply. During the fourth quarter of 2023 and possibly extending into early 2024, we expect that the delay in certification and the shortage of polyurethane-based stimulation leads may cause delays to implant procedures which may adversely affect our business in the EU, including a reduction in our European revenue, and thereby our consolidated revenue, of up to $4 million during the fourth quarter of 2023.
We typically seek to maintain higher levels of inventory to protect ourselves from supply interruptions, and, as a result, we are subject to the risk of inventory obsolescence and expiration, which could lead to inventory impairment charges. For example, during the three months ended September 30, 2022, we recorded a charge of $2.8 million for obsolete inventory and component parts related to product introductions which were completed in October 2022, including the new silicone leads and the Bluetooth®-enabled patient remote.
In the U.S., our products are shipped directly to our U.S. customers and are shipped to our Singapore and Hong Kong distributors on a purchase order basis, primarily by a third-party vendor with a facility in Tennessee, although we do ship some products from our facility in Minnesota. Warehousing and shipping operations for our European customers are handled by a third-party vendor with a facility located in the Netherlands. Shipments of products toNetherlands, and warehousing and shipping operations for our Japanese distributorcustomers are handled from ourby a third-party with a facility in Minnesota.Japan. Customers do not have the right to return a non-defective product, nor do we place product on consignment. Our sales representatives do not maintain trunk stock.
Since our inception in 2007, we have financed our operations primarily through sales of our Inspire system, private placements of our convertible preferred securities, amounts borrowed under our former credit facility, and equity offerings of our common stock. We have devoted significant resources to research and development activities related to our Inspire system, including clinical and regulatory initiatives to obtain marketing approval, and sales and marketing activities. For the three months ended March 31,September 30, 2023, we generated revenue of $127.9$153.3 million with a gross margin of 84.4%84.1% and had a net loss of $15.4$8.5 million compared to revenue of $69.4$109.2 million with a gross margin of 85.6%81.9% and a net loss of $16.7$16.8 million for the three months ended March 31,September 30, 2022. For the nine months ended September 30, 2023, we generated revenue of $432.3 million with a gross margin of 84.1% and had a net loss of $35.9 million compared to revenue of $270.0 million with a gross margin of 83.7% and a net loss of $48.0 million for the nine months ended September 30, 2022. Our accumulated deficit as of March 31,September 30, 2023 was $339.7$360.2 million.
We have invested heavily in product development. Our research and development activities have been centered on driving continuous improvements to our Inspire therapy. We have also made significant investments in clinical studies to demonstrate the safety and efficacy of our Inspire therapy and to support regulatory submissions. We continue to make investments in research and development efforts to develop our next generation Inspire systems and support our future regulatory submissions for expanded indications and for new markets such as additional
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European countries and the Asia Pacific region. For example, in June 2023, we submitted a premarket approval ("PMA") supplement to the FDA for our next generation Inspire system. Also in June 2023, we received approval from the FDA on an expanded indication which includes an increase on the upper limit of the Apnea Hypopnea Index to 100 events per hour from 65, and raises the Body Mass Index ("BMI") warning in the labeling to 40 from 32, and we also received FDA approval of our new physician programmer, called the SleepSync™ programmer, which we expect to formally launch in the U.S. in early 2024. In March 2023, we received FDA approval to offer Inspire therapy to certain pediatric patients with Down syndrome. Insyndrome, and in 2022, we received FDA approval for additional magnetic resonance imaging ("MRI") scan conditions for use with Inspire therapy. This full-body MRI approval expands the Inspire use labeling that previously allowed only head, neck, and extremity MRI scans. Also in 2022, the FDA approved silicone-based stimulation and sensing leads, which provides improved manufacturability, easier system implantation, increased long-term performance, and enhanced reliability.
Our direct-to-consumer marketing includes the use of social media platforms such as Facebook, Google ad placements, and radio and television commercials. In January 2022, we purchased our first national television advertising spots and began airing new TV commercials, and in March 2023, and we began airing additional new television commercials. The objective of this outreach is to bring patients to our website, where they can find educational materials and videos on sleep apnea and the use and benefits of our Inspire therapy, contact information for physicians and clinical sites, and information regarding community awareness events. Further, our team leverages the Inspire Sleep app for patient education. We expect to continue tomaintain or increase our level of direct-to-consumer activities.
We have a call center which we refer to as the Inspire Advisor Care Program ("ACP"). The primary purpose of this program is to assist patients with making a connection with a qualified healthcare provider based on their specific needs. In 2022, we initiated a digital scheduling pilot program to facilitate and streamline patient access to care. We plan to continue to expand this scheduling capability during the remainder of 2023.2023 and 2024.
We also continue to make significant investments to build our sales and marketing organization by increasing the number of U.S. and European sales representatives and continuing our direct-to-consumer marketing efforts in existing and new markets throughout the U.S. and in Europe. During the three months ended March 31,September 30, 2023, we created 1713 new U.S. sales territories, bringing the total to 242274 U.S. territories as of March 31,September 30, 2023. During that same period, we activated 6862 new centers, bringing the total to 9731,107 U.S. medical centers implanting Inspire therapy
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as of March 31,September 30, 2023. At Marchboth of September 30, 2023 and December 31, 2023,2022, ASCs made up 24%23% of our total U.S. implanting centers, upcenters.
During 2023, glucagon-like peptide 1 ("GLP-1s"), a class of drug indicated for diabetes and obesity, continued to gain popularity as a weight-loss drug. OSA is a multifactorial disease with many independent factors including age, gender, weight, and neck circumference. Inspire is designed to address anteroposterior airway collapse, also known as tongue-based collapse. Patients with a higher BMI are subject to a larger neck circumference and present predominantly with lateral-wall collapse. A combination of tongue-based collapse and lateral-wall collapse is identified as a complete concentric collapse of the upper airway which is detected during a DISE procedure. Inspire is contraindicated for complete concentric collapse. While weight loss may help reduce a patient’s Apnea-Hypopnea Index and other OSA symptoms, we have seen from 23% at December 31, 2022.numerous studies that weight loss alone will not resolve OSA for the vast majority of patients. We expect GLP-1s will help patients address their lateral wall collapse, potentially bringing them into our indication. As shown in our ongoing ADHERE patient registry, the average BMI of patients treated with Inspire therapy is 29 and the American Academy of Sleep Medicine guidelines recommend weight loss prior to surgery for patients with BMI over 35 and nonsurgical solutions for patients with BMI over 40. Therefore, there is not a significant overlap in in the Inspire patient population with the GLP-1s today. While we cannot quantify the impact, we believe that there could be a benefit to our business as a result of the GLP-1s, although there can be no assurance of such benefit.
Because of these and other factors, we may incur net losses for the next several years and we may require substantial additional funding, which may include future equity and debt financings.
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Macroeconomic Environment
The global economy is experiencing increased inflationary pressures in part due to global supply chain disruptions, labor shortages, and other impacts offrom COVID-19 and the COVID-19 pandemic and current macroeconomic environment which we anticipate will continue. Higher interest rates and capital costs, higher shipping costs, increased costs of labor, international conflicts and terrorism, and weakening foreign currency exchange rates are creating additional economic challenges. These conditions may cause our customers to decrease or delay orders for our products.
Our operations have been adversely impacted by the inflationary pressures primarily related to labor, raw materials, and component parts. Our inventory on-hand has been constrained by the continuing supply chain challenges and component shortages, although the supply chain constraints eased somewhat throughout 2023. As mentioned above, the delay on EU MDR approval of our silicone-based leads and the shortage of polyurethane-based stimulation leads may cause delays to implant procedures and a reduction in the first quarter of 2023.our European revenue.
COVID-19 Pandemic Update
Our business, operations, and financial condition and results have been and may continue to be impacted by the COVID-19 pandemic.COVID-19. During the first quarter of 2022, resurgences of COVID-19 in various U.S. and international regions impacted our revenue slightly, although surgical volumes had generally returned to pre-pandemic levels by the end of the first quarter, and therefore the impact on the remainder of 2022 was less significant. As discussed above, we have also experienced, and continue to experience, COVID-19-related supply chain issues which has negatively impacted our inventory levels. The extent to which the COVID-19 pandemic continues to impact our results of operations and financial condition will depend on future developments that are highly uncertain and cannot be predicted, including new information that may emerge concerning the severity and longevity of COVID-19 and its variants, the resurgence of COVID-19 in regions that have begun to recover from the initial impact of the pandemic, the impact of COVID-19 on economic activity, and the actions to contain its impact on public health and the global economy.

Components of Our Results of Operations
Revenue
We derive primarily all of our revenue from the sale of our Inspire system to hospitals and ASCs in the U.S., select countries in Europe, Japan, Singapore, and Hong Kong. We recognize revenues from sales of our Inspire system when the customer obtains control of the product, which occurs at a point in time, either upon shipment of the product or receipt of the product, depending on shipment terms.
Our revenue has fluctuated, and may continue to fluctuate, from quarter to quarter due to a variety of factors. For example, we have historically experienced seasonality in our first and fourth quarters and have experienced adverse impacts on our revenue due to the COVID-19 pandemic and foreign currency exchange rates. In addition, in the three months ended September 30, 2023, we believe our revenue growth was adversely impacted by certain changes to our prior authorization support, as well as lack of ENT surgeon capacity. While we believe the impact of the prior authorizations support has improved, the ENT surgeon capacity challenges remain. If such impacts continue, our revenue growth may be further adversely impacted.
Our business has grown rapidly in recent years, resulting in substantially increased revenues, and we expect that our business will continue to grow. However, our revenue growth rate has generally declined recently, and it may continue to do so as a result of the difficulty of maintaining growth rates as our revenues increase to higher levels.
Cost of Goods Sold and Gross Margin
Cost of goods sold consists primarily of acquisition costs for the components of the Inspire system, overhead costs, scrap, and inventory obsolescence, warranty replacement costs, as well as distribution-related expenses such as logistics and shipping costs, net of shipping costs charged to customers. The overhead costs include the cost of material procurement, depreciation expense for production equipment, and operations supervision and
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management personnel, including employee compensation, stock-based compensation, supplies, and travel. We expect cost of goods sold to increase or decrease in absolute dollars primarily as, and to the extent, our revenue grows or declines, respectively.
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We calculate gross margin as gross profit divided by revenue. Our gross margin has been and we expect it will continue to be affected by a variety of factors, including manufacturing costs, the average selling price of our Inspire system, the implementation of cost-reduction strategies, inventory obsolescence costs, which generally occur when new generations of our Inspire system are introduced, and to a lesser extent the sales mix between the U.S. and countries outside of the U.S., as our average selling price in the U.S. tends to be higher than in other countries. Our gross margin may increase slightly to the extent our production volumes increase and we receive discounts on the costs charged by our contract manufacturers, thereby reducing our per unit costs, and when we implement price increases on our products, thereby increasing our revenue. On the other hand, our gross margin may decrease slightly to the extent our yields decrease, or materials and labor prices increase due to supply chain issues and inflation, thereby increasing our per unit costs. However, our gross margin may also fluctuate from quarter to quarter due to seasonality and foreign currency exchange rates.
Our gross margin forin the last nine monthssecond half of 2022 was lower than in previous periods primarily due to inventory obsolescence charges associated with product introductions, additional costs associated with the transition of manufacturing lines to produce our new silicone-based leads, and higher costs of certain component parts which were impacted by inflation and supply chain issues. In 2023, we expect gross margins to be in the range of 83% to 85% given continued higher costs of certain component parts, somewhat offset by the price increase which began taking effect for U.S. customers in May 2022, as well as anticipated manufacturing efficiencies..
Research and Development Expenses
Research and development expenses consist primarily of product development, engineering, clinical studies to develop and support our products, regulatory expenses, quality assurance, testing, consulting services, prelaunch inventory, and other costs associated with the next generation versions of the Inspire system. These expenses include employee compensation, including stock-based compensation, supplies, materials, consulting, and travel expenses related to research and development programs. Additionally, these expenses include clinical study management, payments to clinical investigators, data management and travel expenses for our various clinical studies.
We expense prelaunch inventory as research and development expense in the period incurred unless objective and persuasive evidence exists that regulatory approval and subsequent commercialization of a product candidate is probable and we also expect future economic benefit from the sales of the product candidate to be realized.
We expect research and development expenses to increase in the future as we develop next generation versions of our Inspire system and continue to expand our clinical studies to further expand positive coverage policies from private commercial payors in the U.S. and enter into new markets including additional European countries and the Asia Pacific region. We expect research and development expenses as a percentage of revenue to vary over time depending on the level and timing of initiating new product development efforts and new clinical development activities.
Selling, General and Administrative Expenses
Selling, general and administrative ("SG&A") expenses consist primarily of compensation for personnel, including base salaries, stock-based compensation expense and commissions related to our sales organization, finance, information technology, human resource, and legal functions, as well as spending related to marketing, sales operations, and training and reimbursement personnel. Other SG&A expenses include training physicians, travel expenses, advertising, direct-to-consumer promotional programs, conferences, trade shows and consulting services, professional services fees, audit fees, insurance costs and general corporate expenses, including facilities-related expenses.
We expect SG&A expenses to continue to increase as we expand our commercial infrastructure to both drive and support our planned growth in revenue and as we increase our headcount and expand administrative personnel to
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support our growth and operations as a public company including finance personnel and information technology services. Additionally, we anticipate an increase in our stock-based compensation expense with grants of stock options, restricted stock units, performance stock units, and shares of our common stock purchased pursuant to our employee stock purchase plan.
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Other (Income) Expense
Other (income) expense consists primarily of interest and dividend income, interest expense under our former credit facility, the impacts of foreign currency transactions and remeasurements, and gains and losses on investments.
Seasonality
Historically, we have experienced seasonality in our first and fourth fiscal quarters, and we expect this trend to continue. In the U.S., we have experienced, and may in the future experience, higher sales in the fourth quarter as a result of patients having paid their annual insurance deductibles in full, thereby reducing their out-of-pocket costs. Conversely, 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.

Results of Operations
Three Months EndedThree Months EndedNine Months Ended
March 31,September 30,September 30,
20232022$ Change% Change20232022$ Change% Change20232022$ Change% Change
(in thousands, except percentages)(in thousands, except percentages)
RevenueRevenue$127,897 $69,382 $58,515 84.3 %Revenue$153,302 $109,188 $44,114 40.4 %$432,291 $269,956 $162,335 60.1 %
Cost of goods soldCost of goods sold19,888 10,004 9,884 98.8 %Cost of goods sold24,382 19,786 4,596 23.2 %68,522 43,963 24,559 55.9 %
Gross profitGross profit108,009 59,378 48,631 81.9 %Gross profit128,920 89,402 39,518 44.2 %363,769 225,993 137,776 61.0 %
Gross marginGross margin84.4%85.6%Gross margin84.1%81.9%84.1%83.7%
Operating expenses:Operating expenses:Operating expenses:
Research and developmentResearch and development25,519 11,870 13,649 115.0 %Research and development29,144 20,993 8,151 38.8 %85,484 47,397 38,087 80.4 %
Selling, general and administrativeSelling, general and administrative101,988 63,564 38,424 60.4 %Selling, general and administrative113,247 85,603 27,644 32.3 %327,853 225,853 102,000 45.2 %
Total operating expensesTotal operating expenses127,507 75,434 52,073 69.0 %Total operating expenses142,391 106,596 35,795 33.6 %413,337 273,250 140,087 51.3 %
Operating lossOperating loss(19,498)(16,056)(3,442)21.4 %Operating loss(13,471)(17,194)3,723 (21.7)%(49,568)(47,257)(2,311)4.9 %
Other (income) expense, netOther (income) expense, net(4,290)538 (4,828)(897.4)%Other (income) expense, net(5,271)(593)(4,678)789 %(14,422)286 (14,708)(5,143)%
Loss before income taxesLoss before income taxes(15,208)(16,594)1,386 (8.4)%Loss before income taxes(8,200)(16,601)8,401 (50.6)%(35,146)(47,543)12,397 (26.1)%
Income taxesIncome taxes216 100 116 116.0 %Income taxes340 246 94 38.2 %770 488 282 57.8 %
Net lossNet loss$(15,424)$(16,694)$1,270 (7.6)%Net loss$(8,540)$(16,847)$8,307 (49.3)%$(35,916)$(48,031)$12,115 (25.2)%
Comparison of the Three Months Ended March 31,September 30, 2023 and 2022
Revenue
Revenue increased $58.5$44.1 million, or 84.3%40.4%, to $127.9$153.3 million for the three months ended March 31,September 30, 2023 compared to $69.4$109.2 million for the three months ended March 31,September 30, 2022. These results reflect an increase in sales of our Inspire system of $58.1$41.2 million in the U.S. and an increase of $0.4$2.9 million outside of the U.S. Overall
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revenue growth was primarily due to increased utilization, increased market penetration in existing territories, expansion into new territories, increased physician and patient awareness of our Inspire system, and to a lesser extent, a list price increase that began to impact some U.S. customers in May 2022, partially offset by the factors described under "Components of our Results of Operations - Revenue" above.
Revenue information by region is summarized as follows:
Three Months Ended September 30,
20232022Change
Amount% of RevenueAmount% of Revenue$%
(in thousands, except percentages)
United States$147,514 96.2 %$106,279 97.3 %$41,235 38.8 %
All other countries5,788 3.8 %2,909 2.7 %2,879 99.0 %
Total revenue$153,302 100.0 %$109,188 100.0 %$44,114 40.4 %
Revenue generated in the U.S. was $147.5 million for the three months ended September 30, 2023, an increase of $41.2 million, or 38.8%, compared to the three months ended September 30, 2022. Overall revenue growth was primarily due to increased utilization, increased market penetration in existing territories, expansion into new territories, increased physician and patient awareness of our Inspire system, and to a lesser extent, a list price increase that began to impact some U.S. customers in May 2022.
Revenue generated outside of the U.S. was $5.8 million in the three months ended September 30, 2023, an increase of $2.9 million, or 99.0%, compared to the three months ended September 30, 2022. Revenue growth was primarily due to increased market penetration in existing territories, the expansion of our European sales representatives into new territories, increased sales in the Asia Pacific region, and, we believe, increased physician and patient awareness of our Inspire system.
Cost of Goods Sold and Gross Margin
Cost of goods sold increased $4.6 million, or 23.2%, to $24.4 million for the three months ended September 30, 2023 compared to $19.8 million for the three months ended September 30, 2022. The increase was primarily due to product costs associated with higher sales volume of our Inspire system and additional costs associated with an isolated production issue at a supplier which has since been resolved.
Gross margin increased to 84.1% for the three months ended September 30, 2023 from 81.9% for the three months ended September 30, 2022. Gross margin for the three months ended September 30, 2023 was higher primarily due to $2.8 million of inventory obsolescence charges taken during the third quarter of 2022 associated with new product introductions, which lowered the gross margin during that period.
Research and Development Expenses
Research and development expenses increased $8.2 million, or 38.8%, to $29.1 million for the three months ended September 30, 2023 compared to $21.0 million for the three months ended September 30, 2022. This change was primarily due to an increase of $3.9 million of compensation and employee-related expenses, mainly as a result of increased headcount and stock-based compensation expense. The change also includes an increase of $4.6 million for incremental ongoing research and development costs, including ongoing development of the SleepSync™ platform, the next generation Inspire neurostimulator and physician programmer, and $1.7 million of prelaunch inventory related to our next generation Inspire neurostimulator. These increases were partially offset by a decrease of $0.3 million for clinical and regulatory submissions expenses.
Selling, General and Administrative Expenses
SG&A expenses increased $27.6 million, or 32.3%, to $113.2 million for the three months ended September 30, 2023 compared to $85.6 million for the three months ended September 30, 2022. The primary driver of this change
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Revenue information by region is summarizedwas an increase of $16.3 million in compensation, including salaries, commissions, stock-based compensation, and other employee-related expenses, mainly as follows:
Three Months Ended March 31,
20232022Change
Amount% of RevenueAmount% of Revenue$%
(in thousands, except percentages)
United States$124,485 97.3 %$66,426 95.7 %$58,059 87.4 %
All other countries3,412 2.7 %2,956 4.3 %456 15.4 %
Total revenue$127,897 100.0 %$69,382 100.0 %$58,515 84.3 %
Revenue generateda result of increased headcount. In addition, marketing expenses increased $7.0 million, primarily consisting of direct-to-consumer initiatives, including new national TV advertisements, which began airing in the U.S.first quarter of 2023, and the expansion of our ACP call center. Other drivers of the change to SG&A expenses included an increase in travel expenses of $1.4 million and an increase in general corporate costs of $2.9 million primarily due to consulting fees, legal fees, bank fees, and rent expense.
Other (Income) Expense
Other (income) expense changed by $4.7 million, or 788.9%, to $5.3 million of income, net for the three months ended September 30, 2023 compared to $0.6 million of expense, net for the three months ended September 30, 2022. The change was $124.5primarily due to an increase of $4.1 million in interest and dividend income due to higher interest rates on our higher cash, cash equivalents, and investment balances, a decrease of $0.7 million in interest expense due to the August 2022 early termination of our credit facility, and an increase of $0.1 million in foreign currency translation and remeasurement losses due to exchange rates.
Income Taxes
We recorded a provision for incomes taxes of approximately $0.3 million and $0.2 million for the three months ended March 31,September 30, 2023 and September 30, 2022, respectively.

Comparison of the Nine Months Ended September 30, 2023 and 2022
Revenue
Revenue increased $162.3 million, or 60.1%, to $432.3 million for the nine months ended September 30, 2023 compared to $270.0 million for the nine months ended September 30, 2022. The increase was attributable to a $156.2 million increase in sales of our Inspire system in the U.S and an increase of $58.1$6.2 million or 87.4%, compared tooutside of the three months ended March 31, 2022.U.S. Overall revenue growth was primarily due to increased utilization, increased market penetration in existing territories, expansion into new territories, and increased physician and patient awareness of our Inspire system, and to a lesser extent, a list price increase that began to impact some customers in May 2022, partially offset by the factors described under "Components of our Results of Operations - Revenue" above.
Revenue information by region is summarized as follows:
Nine Months Ended September 30,
20232022Change
Amount% of RevenueAmount% of Revenue$%
(in thousands, except percentages)
United States$416,748 96.4 %$260,581 96.5 %$156,167 59.9 %
All other countries15,543 3.6 %9,375 3.5 %6,168 65.8 %
Total revenue$432,291 100.0 %$269,956 100.0 %$162,335 60.1 %
Revenue generated in the U.S. was $416.7 million for the nine months ended September 30, 2023, an increase of $156.2 million, or 59.9%, compared to the nine months ended September 30, 2022.Revenue growth in the U.S. was primarily due to increased market penetration in existing territories, the expansion into new territories, and, we believe, increased physician and patient awareness of our Inspire system, and to a lesser extent, a list price increase that began to impact some U.S. customers in May 2022. As noted above, U.S. revenue during the three months ended March 31, 2022 was slightly negatively impacted by the COVID-19 pandemic.COVID-19.
Revenue generated outside of the U.S. was $3.4$15.5 million infor the threenine months ended March 31,September 30, 2023, an increase of $0.4$6.2 million, or 15.4%65.8%, compared to the threenine months ended March 31,September 30, 2022. While units sold outsideRevenue growth was primarily due to increased market penetration in existing territories, the U.S.expansion of our European sales
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representatives into new territories, increased 23.7% over the prior year period, sales to distributors in the Asia Pacific region, at a lower average selling price and, unfavorable exchange rates adversely impacted revenue growth.we believe, increased physician and patient awareness of our Inspire system. As noted above, international revenue generated outside the U.S. during the three months ended March 31, 2022 was slightly negatively impacted by the COVID-19 pandemic.COVID-19.
Cost of Goods Sold and Gross Margin
Cost of goods sold increased $9.9$24.6 million, or 98.8%55.9%, to $19.9$68.5 million for the threenine months ended March 31,September 30, 2023 compared to $10.0$44.0 million for the threenine months ended March 31,September 30, 2022. The increase was primarily due to product costs associated with higher sales volume of our Inspire system, higher costs of certain component parts which were impacted by inflation and supply chain issues, and additional costs associated with the transition of manufacturing lines to produce our new silicone-based leads.
Gross margin decreased to 84.4% for the three months ended March 31, 2023 compared to 85.6% for the three months ended March 31, 2022. Gross margin for the three months ended March 31, 2023 was lower primarily due toleads, and higher costs of certain component parts somewhatthat were impacted by inflation and supply chain issues.
Gross margin increased to 84.1% for the nine months ended September 30, 2023 from 83.7% for the nine months ended September 30, 2022. Gross margin for the nine months ended September 30, 2023 was higher primarily due to $2.8 million of inventory obsolescence charges taken during the third quarter of 2022 associated with new product introductions, which lowered the gross margin during that period. Gross margin for the nine months ended September 30, 2023 was negatively impacted by additional manufacturing costs of sensors and lower yields prior to process enhancements, additional costs associated with an isolated production issue at a supplier, and higher costs of certain component parts, partially offset by increased sales volume and manufacturing efficiencies and athe price increase whichthat began taking effect for some U.S. customers in May 2022.
Research and Development Expenses
Research and development expenses increased $13.6$38.1 million, or 115.0%80.4%, to $25.5$85.5 million for the threenine months ended March 31,September 30, 2023 compared to $11.9$47.4 million for the threenine months ended March 31,September 30, 2022. This change was primarily due to an increase of $6.3$21.0 million of incremental ongoing research and development costs, including ongoing development of the SleepSync™ platform, the next generation Inspire neurostimulator and physician programmer. The change also includes an increase of $17.1 million of compensation and employee-related expenses, mainly as a result of increased headcount and stock-based compensation expense, and $7.3$4.7 million for incremental ongoing research and development costs, including ongoing development of the Inspire Cloud, theprelaunch inventory related to our next generation Inspire neurostimulator and the physician programmer.neurostimulator.
Selling, General and Administrative Expenses
SG&A expenses increased $38.4$102.0 million, or 60.4%45.2%, to $102.0$327.9 million for the threenine months ended March 31,September 30, 2023 compared to $63.6$225.9 million for the threenine months ended March 31,September 30, 2022. The primary driver of this change was an increase of $22.8$59.1 million in compensation, including salaries, commissions, stock-based compensation, and other employee-related expenses, mainly as a result of increased headcount. In addition, marketing expenses increased $9.9$28.5 million, primarily consisting of direct-to-consumer initiatives, including new national TV advertisements, which began airing in the first quarter ofMarch 2023, and the expansion of our ACPAdvisor Care Program call center. Other drivers of the change to
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SG&A expenses included an increase in travel expenses of $3.4$6.3 million and an increase in general corporate costs of $2.3$8.1 million primarily due to bank fees, consulting fees, legal fees, computer equipment and software, consulting fees, legal fees and bank fees.office rent expense.
Other (Income) Expense, Net
Other (income) expense, net changed by $4.8$14.7 million, or 897.4%, to $4.3$14.4 million of income, net for the threenine months ended March 31,September 30, 2023 compared to $0.5$0.3 million of expense net for the threenine months ended March 31,September 30, 2022. TheThis change was primarily due to an increase of $4.2$13.0 million in interest and dividend income due to higher interest rates on our higher cash, and cash equivalents and investment balances, somewhat offset by a decrease of $0.5$1.7 million in interest expense due to the August 2022 early termination of our credit facility, and a net change of $0.1 million in foreign currency translation and remeasurement gains due to exchange rates and loss on investments.facility.
Income Taxes
We recorded a provision for incomesincome taxes of approximately $0.2$0.8 million and $0.1$0.5 million for the threenine months ended March 31,September 30, 2023 and March 31,September 30, 2022, respectively.
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Liquidity and Capital Resources
As of March 31,September 30, 2023, we had cash, cash equivalents, and available-for-sale debt securities of $452.1$467.2 million, an increase of $0.6$15.8 million from $451.4 million as of December 31, 2022. Working capital totaled $473.7$499.6 million as of March 31,September 30, 2023, an increase of $4.9$30.8 million from December 31, 2022. We define working capital as current assets less current liabilities. The increase in working capital was primarily due to the following factors:
a decreasean increase of $10.9$124.5 million in accrued expenses which decreased primarily due to the payment of year-end bonuses and commissions;short-term investments;
an increase of $3.8$14.2 million in inventory balances which increased as supply chain issues ease;
an increase of $0.6$10.2 million in accounts receivable due to higher sales which occurred during the third quarter of 2023;
a decrease of $4.4 million in accrued expenses which decreased primarily due to the payment of year-end bonuses and commissions; and
an increase of $2.3 million in prepaid expense and other current assets;assets which increased primarily due to prepaid insurance and other prepaid expenses.
The increase in working capital was partially offset by the following factors:
a $0.5$111.7 million increasedecrease in cash and cash equivalents, primarily due to the purchase of short- and long-term available for sale investments, offset somewhat by sales of the Inspire system and proceeds from the exercise of stock options, somewhat offset by cash used to support operations;options; and
an increase of $0.1 million in short-term investments.
The increase in working capital was offset by the following factors:
a $9.6$13.2 million increase in accounts payable, generally due to our business volume and headcount growth from the prior year; and
a decrease of $1.5 million in accounts receivable due to collection on higher sales which occurred during the fourth quarter of 2022.year.
We proactively manage our access to capital to support liquidity and continued growth. Our sources of capital include sales of our Inspire system and registered offerings of our common stock. In August 2022, we completed a follow-on offering that included our offer and sale of 1,150,000 shares of common stock at a public offering price of $215.00 per share. We received net proceeds of approximately $243.8 million after deducting underwriting discounts, commissions, and offering expenses. During the quarter ended September 30, 2022, we repaid all amounts outstanding under our former credit facility. See Note 5 to our audited financial statements4 in this Quarterly Report on Form 10-Q for additional information on our previous credit facility.
The primary objective of our investment activities is to preserve our capital for the purpose of funding operations while at the same time maximizing the income we receive from our investments without significantly increasing risk or decreasing availability. To achieve these objectives, our investment policy allows us to maintain a portfolio of certain types of debt securities issued by the U.S. government and its agencies, corporations with investment-grade credit ratings, or commercial paper and money market funds issued by the highest quality financial and non-financial companies. At March 31,September 30, 2023, we had $395.0$284.4 million in money market funds, and $9.9$99.3 million of investments in U.S. government securities, and no investments with a contractual maturity over one year.
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deposit, and asset-asset-backed securities. See Note 2 in this Quarterly Report on Form 10-Q for additional information on our investments.
In the threenine months ended March 31,September 30, 2023, our R&D and SG&A expenditures increased significantly over the prior year levels, and we anticipate further increases in 2023.during the remainder of 2023 and 2024. Our SG&A expenditures, primarily for increasing headcount and advertising, may exceed any associated increases in revenues, and therefore would reduce our cash flow from operations. We also anticipate R&D expenses will continue to be significant in 2023 and 2024, primarily related to the ongoing development of the SleepSync™ platform and the next generation Inspire neurostimulator and the SleepSync™ platform.neurostimulator.
We spent $3.8$15.6 million on purchases of property and equipment in the threenine months ended March 31,September 30, 2023, mainly on testing systems and production equipment for our next generation Inspire system as well as our Inspire Cloud.SleepSync™ platform. We anticipate further capital expenditures in 2023 and 2024, primarily for additional production equipment and, to a lesser extent, leasehold improvements on our corporate office.office buildings.
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As of March 31,September 30, 2023, we did not have any off-balance sheet arrangements that have, or are reasonably likely to have, a current or future material effect on our financial condition, results of operations, liquidity, capital expenditures or capital resources.
We believe that our existing cash and cash equivalents and investments, which totaled $452.1$467.2 million as of March 31,September 30, 2023, together with cash flow from operations, will provide liquidity sufficient to meet our cash needs and fund our operations and planned capital expenditures for at least the next 12 months. There can be no assurance, however, that our business will continue to generate cash flows at historic levels.the same levels achieved in prior periods.
Beyond the next 12 months, our cash requirements will depend extensively on the timing of market introduction, and extent of market acceptance of, our Inspire system. Our long-term cash requirements also will be significantly impacted by the level of our investment in commercialization, entry and expansion into new markets such as Hong Kong and Australia, whether we make strategic acquisitions, and competition. We cannot accurately predict our long-term cash requirements at this time. Additionally, the COVID-19 pandemic has negatively impacted the global economy, disrupted global supply chains and created significant volatility and disruption of financial markets. An extended period of global supply chain and economic disruption could materially affect our business, results of operations, access to sources of liquidity, and financial condition. We may seek additional sources of liquidity and capital resources through additional securities offerings or through borrowings under a new credit facility. There can be no assurance that such transactions will be available to us on favorable terms, if at all.
Cash Flows
The following table presents a summary of our cash flow for the periods indicated:
Three Months EndedNine Months Ended
March 31,September 30,
2023202220232022
(in thousands)(in thousands)
Net cash provided by (used in):Net cash provided by (used in):Net cash provided by (used in):
Operating activitiesOperating activities$(1,344)$(12,748)Operating activities$7,386 $(7,700)
Investing activitiesInvesting activities(3,753)(1,465)Investing activities(143,099)(16,646)
Financing activitiesFinancing activities5,631 3,044 Financing activities24,065 227,788 
Effect of exchange rate on cashEffect of exchange rate on cash(7)Effect of exchange rate on cash(47)(101)
Net increase (decrease) in cash and cash equivalents$540 $(11,176)
Net (decrease) increase in cash and cash equivalentsNet (decrease) increase in cash and cash equivalents$(111,695)$203,341 
Operating Activities
The net cash used inprovided by operating activities was $1.3$7.4 million for the threenine months ended March 31,September 30, 2023 and consisted of a net loss of $15.4$35.9 million, non-cash charges of $19.2$64.2 million, and a decrease in net operating assets of $5.1$20.9 million. The non-cash charges consisted primarily of stock-based compensation, which increased mainly as a result of granting more stock options, restricted stock units, and performance stock units to morea greater number of employees at a higher fair market value. The remainder of the non-cash charges included depreciation and amortization expense, non-cash lease expense, and stock issued for services rendered.rendered, and other, net. Operating assets include accounts receivable which
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decreased due to collections on the higher sales volume we typically experience late in the fourth quarter. Operating assets also include inventories, which increased as supply chain constraints eased, and to a lesser extent prepaid expenses and other current assets.assets, which increased primarily due to prepaid insurance and other prepaid expenses. Operating assets also include accounts receivable, which increased due to higher sales volume. Operating liabilities includesinclude accounts payable, which increased generally due to our increased business volume year-over-year and the costs to support the growth of our operations, and accrued expenses, which decreased primarily due to the payment of year-end bonuses and commissions.
The net cash used in operating activities was $12.7$7.7 million for the threenine months ended March 31,September 30, 2022 and consisted of a net loss of $16.7$48.0 million, non-cash charges of $10.5$38.7 million, and a decrease in net operating assets of $6.5$1.6 million. The non-cash charges consisted primarily of stock-based compensation, which increased mainly as a result of granting more stock options and restricted stock to a greater number of employees at a higher fair market
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value, as well as the introduction of performance stock unit grants. The remainder of the non-cash charges included depreciation and amortization, non-cash lease expense, stock issued for services rendered, accretion of the debt discount, and accretion of the investment discount.other, net. Operating assets includes inventories, which increased due to manufacturing of systems inventory to meet increased sales and to establish safety stock to avoid inventory shortages in the event of COVID-related production or supply issues. Operating assets also include accounts receivable which increased slightly over the prior year-end balance,due to higher sales, and prepaid expenses and other current assets which decreased slightly.increased primarily due to prepaid insurance. Operating liabilities includes accrued expenses,assets also include inventories, which decreased primarily due to the payment of accrued compensation as annual bonuses were paid, andsales demand. Operating liabilities include accounts payable, which increased generally due to our increased business volume year-over-year and the costs to support the growth of our operations, includingand accrued expenses, which increased primarily due to compensation and personnel-related costs and the accrual of R&D and inventory related costs.
Investing Activities
Net cash used in investing activities for the threenine months ended March 31,September 30, 2023 was $3.8$143.1 million and consisted primarily of the purchase of investments of $137.3 million, the purchases of property and equipment.equipment of $15.6 million, and the purchase of strategic investments of $0.3 million, partially offset by the proceeds from sales or maturities of investments of $10.0 million.
Net cash provided byused in investing activities for the threenine months ended March 31,September 30, 2022 was $1.5$16.6 million and consisted of purchases of property and equipment of $1.2$6.1 million and the purchase of an investmentstrategic investments of $0.3$10.5 million.
Financing Activities
Net cash provided by financing activities was $5.6$24.1 million for the threenine months ended March 31,September 30, 2023 and consisted of $7.4$24.5 million in proceeds from the exercise of stock options and $2.8 million in proceeds from the issuance of common stock from our ESPP, somewhat offset by $1.7$3.2 million of taxes paid on net share settlement of RSUs.
Net cash provided by financing activities was $3.0$227.8 million for the threenine months ended March 31,September 30, 2022 and consisted primarily of proceeds from the offering of common stock of $243.8 million, as well as proceeds from the exercise of stock options of $3.1$6.4 million, and proceeds from the issuance of common stock from our ESPP of $2.1 million, partially offset by $24.5 million in payments on our long-term debt obligation, which we prepaid in August 2022, and less than $0.1 million of taxes paid to net share settlement of RSUs.

Contractual Obligations and Commitments
There have been no material changes to our short-term and long-term anticipated cash requirements under contractual obligations, other than as described in Note 3 in this Quarterly Report on Form 10-Q, from those described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022.
Critical Accounting Policies and Estimates
Our critical accounting policies and estimates are described in "Management's Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022. We have reviewedOther than the addition of prelaunch inventory described in Note 2 in this Quarterly Report on Form 10-Q and determined that those critical accounting policies and estimates remainbelow, no material changes were made to our critical accounting policies and estimates as of andfrom those disclosed in our Annual Report on Form 10-K for the three monthsfiscal year ended MarchDecember 31, 2023.2022.
Prelaunch inventory
We capitalize prelaunch inventory prior to receiving regulatory approval if regulatory approval and subsequent commercialization of a product is probable and we also expect future economic benefit from the sales of the product to be realized. Prior to this, we expense prelaunch inventory as research and development expense in the period incurred. For prelaunch inventory that is capitalized, we consider a number of specific facts and circumstances, including the product’s historical shelf life, the product's current status in the development and regulatory approval
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process, results from related clinical trials, results from meetings with relevant regulatory agencies prior to the filing of regulatory applications, potential obstacles to the approval process, historical experience, viability of commercialization and market trends. If either the regulatory approval or market acceptance post-approval do not occur at all or on a timely basis prior to the inventory shelf-life expiration, we may be required to write-off some or all prelaunch inventory, which could affect our financial condition and financial results.
Recent Accounting Pronouncements
We have reviewed all recently issued standards and have determined that such standards will not have a significant impact on our consolidated financial statements or do not otherwise apply to our operations.

Item 3.    Quantitative and Qualitative Disclosures About Market Risk.
Interest Rate Risk
The risk associated with fluctuating interest rates is primarily limited to our cash equivalents which are carried at quoted market prices and our short-term investments. We do not currently use or plan to use financial derivatives in our investment portfolio. A hypothetical 1% increase in interest rates during the threenine months ended March 31,September 30, 2023 would have impacted interest income on our consolidated financial statements by approximately $5.2$16.2 million.
Credit Risk, Foreign Currency Risk, and Inflation Risk
For market risks related to changes in credit, foreign currency, and inflation, reference is made to Item 7A “Quantitative and Qualitative Disclosures About Market Risk” contained in Part II of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022. Our exposure to these risks has not materially changed from those disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, other than as described below.
As of March 31,September 30, 2023 and December 31, 2022, our cash, cash equivalents, and investments were maintained with financial institutions which we believe have sufficient assets and liquidity to conduct their operations in the ordinary course of business with little or no credit risk to us, however our cash balances were in excess of insured limits. Market conditions can impact the viability of where our cash is held. In the event of failure of any of the financial institutions where we maintain our cash and cash equivalents, there can be no assurance that we will be able to access uninsured funds in a timely manner or at all.

Item 4.    Controls and Procedures.
Evaluation of disclosure controls and procedures
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, refers to controls and other procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our management, with the participation of our chief executive officer and our chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on that evaluation, our chief executive officer and our chief financial officer concluded that our disclosure controls and
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procedures were effective, at the reasonable assurance level, as of the end of the period covered by this Quarterly Report on Form 10-Q.
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Changes in internal control over financial reporting.
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter ended March 31,September 30, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II—OTHER INFORMATION

Item 1.    Legal Proceedings.
From time to time, we may be involved in claims and proceedings arising in the course of our business. The outcome of any such claims or proceedings, regardless of the merits, is inherently uncertain. We are not party to any material legal proceedings.

Item 1A.    Risk Factors.
For a discussion of our potential risks and uncertainties, see the information in "Part I, Item IA. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022. 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, 2022.2022, other than the following:
We may not receive the necessary approvals or certifications for our future products or expanded indications, and failure to timely obtain necessary approvals or certifications for our future products or expanded indications would adversely affect our ability to grow our business.
An element of our strategy is to continue to upgrade our products, add new features and expand the indications and uses for our current products. In the U.S., before we can market a new medical device, or a new use of, or claim for, or significant modification to, an existing product, we must first receive PMA from the FDA. In the process of obtaining PMA, which was required for our Inspire system, the FDA must determine that a proposed device is safe and effective for its intended use based, in part, on extensive data, including, but not limited to, technical, pre-clinical, clinical study, manufacturing and labeling data. The PMA process is typically required for devices that are deemed to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices.
Modifications to products that are approved through a PMA application generally require FDA approval. PMA can be expensive, lengthy and uncertain. The process of obtaining a PMA is costly and more uncertain than the 510(k) clearance process used for lower risk devices. Despite the time, effort and cost, a device may not be approved by the FDA. Any delay or failure to obtain necessary regulatory approvals could harm our business. Furthermore, even if we are granted regulatory approval, it may include significant limitations on the indicated uses for the device, which may limit the market for the device.
The FDA and other regulatory authorities or notified bodies outside the U.S. can delay, limit or deny approval or certification of a device for many reasons, including:
our inability to demonstrate to the satisfaction of the FDA or the applicable foreign regulatory entity or notified body that our products are safe or effective for their intended uses;
the disagreement of the FDA or the applicable foreign regulatory authority or notified body with the design or implementation of our clinical studies or the interpretation of data from pre-clinical studies or clinical studies;
serious and unexpected adverse device effects experienced by participants in our clinical studies;
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the data from our pre-clinical studies and clinical studies may be insufficient to support approval or certification, where required;
our inability to demonstrate that the clinical and other benefits of the device outweigh the risks;
the manufacturing process or facilities we use may not meet applicable requirements; and
the potential for approval policies or regulations of the FDA or applicable foreign regulatory authorities to change significantly in a manner rendering our clinical data or regulatory filings insufficient for clearance, approval or certification.
In addition, the FDA or other regulatory authorities or notified bodies outside the U.S. may change their approval or certification policies, adopt additional regulations or revise existing regulations, or take other actions, which may prevent or delay approval or certification of our future products under development or impact our ability to modify our currently cleared or certified products on a timely basis. Such policy or regulatory changes could impose additional requirements or time delays upon us that could delay our ability to obtain new approvals or certifications, increase the costs of compliance, adversely impact our revenues or inventory forecasting or restrict our ability to maintain our current approval or certification.
Subject to the transitional provisions, in order to sell our products in EU member states, our products must comply with the general safety and performance requirements of the EU Medical Devices Regulation, which repeals and replaces EU Medical Devices Directive and the AIMDD. Compliance with these requirements is a prerequisite to be able to affix the European Conformity (“CE”) mark to our products, without which they cannot be sold or marketed in the EU. To demonstrate compliance with the general safety and performance requirements, we must undergo a conformity assessment procedure, which varies according to the type of medical device and its (risk) classification. Except for low risk medical devices (Class I), where the manufacturer can self-assess the conformity of its products with the general safety and performance requirements (except for any parts which relate to sterility, metrology or reuse aspects), a conformity assessment procedure requires the intervention of a notified body. The notified body would typically audit and examine the technical file and the quality system for the manufacture, design and final inspection of our devices. If satisfied that the relevant product conforms to the relevant general safety and performance requirements, the notified body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity. The manufacturer may then apply the CE mark to the device, which allows the device to be placed on the market throughout the EU. If we fail to comply with applicable laws and regulations, we would be unable to affix the CE mark to our products, which would prevent us from selling them within the EU. The aforementioned EU rules are generally applicable in the EEA, and non-compliance with the above requirements would also prevent us from selling our products in these three countries.
Once devices are certified under the EU Medical Devices Regulation, we must inform the notified body that carried out the conformity assessment of the medical devices that we market or sell in the EU and the EEA of any planned substantial changes to our quality system or substantial changes to our medical devices that could affect compliance with the general safety and performance requirements laid down in Annex I to the EU Medical Devices Regulation or cause a substantial change to the intended use for which the device has been CE marked. The notified body will then assess the planned changes and verify whether they affect the products’ ongoing conformity with the EU Medical Devices Regulation. If the assessment is favorable, the notified body will issue a new certificate of conformity or an addendum to the existing certificate attesting compliance with the general safety and performance requirements and quality system requirements laid down in the Annexes to the EU Medical Devices Regulation. The notified body may disagree with our proposed changes or take more time than anticipated to review and assess applications resulting in regulatory delays (See Part I., "Item 1A. Risk Factors — Risks Related to Government Regulation” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 for additional information regarding disruptions faced by notified bodies). As a consequence, product introductions or modifications could be delayed or canceled, which could adversely affect our ability to grow our business. For example, we applied for certification of silicone-based leads under the EU Medical Devices Regulation in December 2021 in order to replace the polyurethane-based leads, two components of the Inspire system currently used only in the European market. However, designated notified bodies currently have severe capacity constraints, and review times have lengthened significantly, including for our certification application. We forecasted our polyurethane-based leads inventory based on our notified body’s original lead-time for certification of the silicone-based leads, and we now expect to obtain certification of our silicone-based leads in the first quarter of 2024. Because of these
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unanticipated delays, we began experiencing an inventory issue related to our polyurethane-based stimulation leads during the third quarter of 2023. In the interim, we received a derogation from the Dutch national competent authority allowing us to place the silicone-based leads on the market until April 1, 2024 or until we receive certification under the EU Medical Devices Regulation, whichever occurs first. We are also pursuing similar derogations in several other EU member states. However, such derogations are only granted at the national level, and we cannot be certain that national competent authorities of the other EU member states will grant a derogation similar to the Dutch authority. Until we obtain certification under the EU Medical Devices Regulation or these derogations are received, we may only sell our polyurethane-based leads in the EU where the stimulation lead is in low supply. During the fourth quarter of 2023 and possibly extending into early 2024, we expect that the delay in certification and the shortage of polyurethane-based stimulation leads may cause delays to implant procedures which may adversely affect our business in the EU, including a reduction in our European and, thereby, our consolidated revenue.

Item 2.    Unregistered Sales of Equity Securities, and Use of Proceeds.Proceeds, and Issuer Purchases of Equity Securities.
None.

Item 3.    Defaults Upon Senior Securities.
None.

Item 4.    Mine Safety Disclosures.
Not applicable.

Item 5.    Other Information.
(a) None.
(b) None.
(c) On August 10, 2023, Philip J. Ebeling, Chief Operating Officer, adopted a Rule 10b5-1 trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of up to 21,600 shares of the Company’s common stock until August 9, 2024.
On August 15, 2023, Randall Ban, Chief Commercialization Officer, adopted a Rule 10b5-1 trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of up to16,339 shares of the Company’s common stock until February 22, 2024.
On August 17, 2023, Steven Jandrich, Vice President, Human Resources, adopted a Rule 10b5-1 trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of up to 10,000 shares of the Company’s common stock until March 29, 2024.
On August 28, 2023, Timothy P. Herbert, Chief Executive Officer, adopted a Rule 10b5-1 trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of up to 40,000 shares of the Company’s common stock until June 30, 2024. This trading arrangement was adopted by the Timothy P. Herbert 2018 Family Continuation Trust, of which Mr. Herbert is a trustee.
On August 29, 2023, Georgia Garinois-Melenikiotou, Director, adopted a Rule 10b5-1 trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of up to 3,225 shares of the Company’s common stock until August 29, 2024.
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On August 31, 2023, Richard J. Buchholz, Chief Financial Officer, adopted a Rule 10b5-1 trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of up to 15,000 shares of the Company’s common stock until August 30, 2024.
There were no other Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements adopted, modified or terminated by the Company’s directors and executive officers during the quarter ended September 30, 2023.


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Item 6.    Exhibits.
Exhibit
Number
Exhibit
Number
DescriptionFormFile No.ExhibitFiling
Date
Filed/
Furnished
Herewith
Exhibit
Number
DescriptionFormFile No.ExhibitFiling
Date
Filed/
Furnished
Herewith
3.1 3.1 8-K001-384683.15/7/20183.1 8-K001-384683.15/7/2018
3.2 3.2 8-K001-384683.25/7/20183.2 8-K001-384683.25/7/2018
10.110.110-K001-3846810.102/10/2310.1*
31.1 31.1 *31.1 *
31.2 31.2 *31.2 *
32.1 32.1 **32.1 **
32.2 32.2 **32.2 **
101.INS101.INSInline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document*101.INSInline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document*
101.SCH101.SCHInline XBRL Taxonomy Extension Schema Document*101.SCHInline XBRL Taxonomy Extension Schema Document*
101.CAL101.CALInline XBRL Taxonomy Extension Calculation Linkbase Document*101.CALInline XBRL Taxonomy Extension Calculation Linkbase Document*
101.DEF101.DEFInline XBRL Taxonomy Extension Definition Linkbase Document*101.DEFInline XBRL Taxonomy Extension Definition Linkbase Document*
101.LAB101.LABInline XBRL Taxonomy Extension Label Linkbase Document*101.LABInline XBRL Taxonomy Extension Label Linkbase Document*
101.PRE101.PREInline XBRL Taxonomy Extension Presentation Linkbase Document*101.PREInline XBRL Taxonomy Extension Presentation Linkbase Document*
104104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)*104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)*

*    Filed herewith.
**    Furnished herewith.

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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 thereunto duly authorized.
Inspire Medical Systems, Inc.
Date:May 2,November 7, 2023By:/s/ TIMOTHY P. HERBERT
Timothy P. Herbert
President, Chief Executive Officer and Director
(principal executive officer)
Date:May 2,November 7, 2023By:/s/ RICHARD J. BUCHHOLZ
Richard J. Buchholz
Chief Financial Officer
(principal financial officer and principal accounting officer)

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