insp-20240331

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, 2024 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

______________________________

Inspire Medical Systems, Inc.

(Exact name of registrant as specified in its charter)

______________________________


Delaware			26-1377674
(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 class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 par value per share

INSP

New York Stock Exchange

Indicate by check mark whether the registrant (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 May 1, 2024, the registrant had 29,711,048 shares of common stock, $0.001 par value per share, outstanding.

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		Page
	Forward-Looking Statements	3

PART I.	FINANCIAL INFORMATION	5
Item 1.	Consolidated Financial Statements	5
	Balance Sheets	5
	Statements of Operations and Comprehensive Loss	6
	Statements of Stockholders' Equity	7
	Statements of Cash Flows	8
	Notes to Consolidated Financial Statements	9
Item 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	24
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	33
Item 4.	Controls and Procedures	34

PART II.	OTHER INFORMATION	34
Item 1.	Legal Proceedings	34
Item 1A.	Risk Factors	35
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	37
Item 3.	Defaults Upon Senior Securities	37
Item 4.	Mine Safety Disclosures	37
Item 5.	Other Information	37
Item 6.	Exhibits	38

	Signatures	39

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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 fact 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 macroeconomic trends on our business, financial results and financial position, prospective products, international product approvals and commercializations, our expectations regarding the final reimbursement levels for Inspire therapy procedures, research and development costs, timing and likelihood of success, other insurance providers' plans to begin approving our Inspire therapy, our sales and marketing initiatives, potential supply chain disruptions, and the plans and objectives of management for future operations.

In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this 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 public health crises and pandemics;

•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, including our next generation Inspire therapy 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;

•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, certifications, 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, 2023, as updated by “Part I, Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations" in this Quarterly Report.

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, 2024		December 31, 2023
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	175,416	$	185,537
Investments, short-term	265,945		274,838
Accounts receivable, net of allowance for credit losses of $256 and $1,648, respectively	72,333		89,884
Inventories, net	48,974		33,885
Prepaid expenses and other current assets	9,546		9,595
Total current assets	572,214		593,739
Investments, long-term	27,803		9,143
Property and equipment, net	52,281		39,984
Operating lease right-of-use assets	22,248		22,667
Other non-current assets	11,296		11,278
Total assets	$	685,842	$	676,811
Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$	43,802	$	38,839
Accrued expenses	28,370		39,266

Total current liabilities	72,172		78,105

Operating lease liabilities, non-current portion	24,500		24,846
Other non-current liabilities	146		1,346
Total liabilities	96,818		104,297
Stockholders' equity:
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; 29,676,095 and 29,560,464 issued and outstanding at March 31, 2024 and December 31, 2023, respectively	30		30
Additional paid-in capital	944,298		917,107
Accumulated other comprehensive income	124		800
Accumulated deficit	(355,428)		(345,423)
Total stockholders' equity	589,024		572,514
Total liabilities and stockholders' equity	$	685,842	$	676,811

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,
	2024		2023
Revenue	$	164,010	$	127,897
Cost of goods sold	24,757		19,888
Gross profit	139,253		108,009
Operating expenses:
Research and development	28,850		25,519
Selling, general and administrative	125,621		101,988
Total operating expenses	154,471		127,507
Operating loss	(15,218)		(19,498)
Other (income) expense:
Interest and dividend income	(5,923)		(4,273)

Other expense (income), net	60		(17)
Total other income	(5,863)		(4,290)
Loss before income taxes	(9,355)		(15,208)
Income taxes	650		216
Net loss	(10,005)		(15,424)
Other comprehensive loss:
Foreign currency translation (loss) gain	(134)		105
Unrealized (loss) gain on investments	(542)		13
Total comprehensive loss	$	(10,681)	$	(15,306)
Net loss per share, basic and diluted	$	(0.34)	$	(0.53)

Weighted average common shares used to compute net loss per share, basic and diluted	29,615,166		29,089,950

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, 2024
	Common Stock
	Shares	Amount		Additional Paid-In Capital		Accumulated Other Comprehensive Income (Loss)		Accumulated Deficit		Total Stockholders' Equity
Balance at December 31, 2023	29,560,464	$	30	$	917,107	$	800	$	(345,423)	$	572,514
Stock options exercised	88,276	—		3,616		—		—		3,616
Vesting of restricted stock units	41,185	—		—		—		—		—
Shares held for tax withholdings	(14,373)	—		(2,848)		—		—		(2,848)
Issuance of common stock	543	—		101		—		—		101
Stock-based compensation expense	—	—		26,322		—		—		26,322
Other comprehensive loss	—	—		—		(676)		—		(676)
Net loss	—	—		—		—		(10,005)		(10,005)
Balance at March 31, 2024	29,676,095	$	30	$	944,298	$	124	$	(355,428)	$	589,024


	Three Months Ended March 31, 2023
	Common Stock
	Shares	Amount		Additional Paid-In Capital		Accumulated Other Comprehensive (Loss) Income		Accumulated Deficit		Total Stockholders' Equity
Balance at December 31, 2022	29,008,368	$	29	$	820,335	$	(86)	$	(324,270)	$	496,008
Stock options exercised	142,167	—		7,377		—		—		7,377
Vesting of restricted stock units	18,852	—		—		—		—		—
Shares held for tax withholdings	(6,750)	—		(1,746)		—		—		(1,746)
Issuance of common stock	364	—		90		—		—		90
Stock-based compensation expense	—	—		18,225		—		—		18,225
Other comprehensive income	—	—		—		118		—		118
Net loss	—	—		—		—		(15,424)		(15,424)
Balance at March 31, 2023	29,163,001	$	29	$	844,281	$	32	$	(339,694)	$	504,648

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,
	2024		2023
Operating activities
Net loss	$	(10,005)	$	(15,424)
Adjustments to reconcile net loss:
Depreciation and amortization	839		593
Accretion of investment discount	(2,469)		(1)
Non-cash lease expense	418		265
Stock-based compensation expense	26,322		18,225
Non-cash stock issuance for services rendered	101		90
Provision (benefit) for estimated credit losses	(1,392)		—
Changes in operating assets and liabilities:
Accounts receivable	18,962		1,489
Inventories	(15,089)		(3,777)
Prepaid expenses and other current assets	13		(579)
Accounts payable	3,558		8,390
Accrued expenses and other liabilities	(12,398)		(10,615)
Net cash provided by (used in) operating activities	8,860		(1,344)
Investing activities
Purchases of property and equipment	(11,696)		(3,753)
Purchases of investments	(55,739)		—
Proceeds from sales or maturities of investments	47,900		—

Net cash used in investing activities	(19,535)		(3,753)
Financing activities


Proceeds from the exercise of stock options	3,616		7,377
Payment of taxes on net share settlement of equity awards	(2,848)		(1,746)

Net cash provided by financing activities	768		5,631
Effect of exchange rate on cash	(214)		6
(Decrease) increase in cash and cash equivalents	(10,121)		540
Cash and cash equivalents at beginning of period	185,537		441,592
Cash and cash equivalents at end of period	$	175,416	$	442,132
Supplemental cash flow information

Property and equipment included in accounts payable and accrued expenses	$	5,458	$	2,577

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 and certain Asia Pacific markets since 2021.

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited 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, 2023.

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. Cash is carried at cost, which approximates fair value, and cash equivalents, which consist of money market funds, are stated at fair value.

Foreign Currency

Our functional and reporting currency is the U.S. dollar. Our subsidiaries have functional currency in 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 of the transaction. Foreign currency transaction gains and losses and the impacts of foreign currency remeasurement are recognized in other expense, net in the consolidated statements of operations and comprehensive loss. For the three-month periods ended March 31, 2024 and 2023, we recognized $0.1 million and $0.0 million of loss, net, respectively. 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 and $0.2 million of unrecognized gain in our accumulated other comprehensive income (loss) balance as of March 31, 2024 and December 31, 2023, respectively.

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Inspire Medical Systems, Inc.

Notes to Consolidated Financial Statements (unaudited)

(Table amounts in thousands, except share and per share amounts)

Investments

Our investments are classified as available-for-sale and consisted of the following:


	March 31, 2024
	Amortized		Unrealized Gross				Aggregate
	Cost		Gains		Losses		Fair Value
Short-Term:
Commercial paper	$	5,402	$	—	$	(8)	$	5,394
Corporate debt securities	28,719		26		—		28,745
Certificates of deposit	7,643		6		(2)		7,647

U.S. treasury debt securities	224,085		76		(2)		224,159
Short-term investments	$	265,849	$	108	$	(12)	$	265,945
Long-Term:
Corporate debt securities	$	1,166	$	5	$	—	$	1,171
Certificates of deposit	2,994		6		—		3,000
Asset-backed securities	911		—		(1)		910
U.S. treasury debt securities	22,801		—		(79)		22,722
Long-term investments	$	27,872	$	11	$	(80)	$	27,803


	December 31, 2023
	Amortized		Unrealized Gross				Aggregate
	Cost		Gains		Losses		Fair Value
Short-Term:
Commercial paper	$	2,950	$	1	$	—	$	2,951
Corporate debt securities	30,154		61		—		30,215
Certificates of deposit	2,953		15		—		2,968

U.S. treasury debt securities	238,237		467		—		238,704
Short-term investments	$	274,294	$	544	$	—	$	274,838
Long-Term:
Corporate debt securities	$	3,109	$	13	$	—	$	3,122
Asset-backed securities	1,170		1		—		1,171
U.S. treasury debt securities	4,838		12		—		4,850
Long-term investments	$	9,117	$	26	$	—	$	9,143

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 $0.0 million and $0.6 million of unrecognized gain in our accumulated other comprehensive income (loss) balance at March 31, 2024 and December 31, 2023, respectively. Any realized gains and losses are calculated on the specific identification method and reported net in other expense, net in the consolidated statements of operations and comprehensive loss. For both of the three months ended March 31, 2024 and 2023, we recognized $0 of realized gain or loss.

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Inspire Medical Systems, Inc.

Notes to Consolidated Financial Statements (unaudited)

(Table amounts in thousands, except share and per share amounts)

As of March 31, 2024 and December 31, 2023, we had no investments with a contractual maturity of greater than three years. 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, 2024. Each reporting period, we evaluate whether declines in fair value below carrying value are due to expected credit losses, as well as our ability and intent to hold the investment until a forecasted recovery occurs. Expected credit losses, not to exceed the amount of the unrealized loss, are recorded as an allowance through other expense, net in the consolidated statements of operations and comprehensive loss. The total allowance for credit losses was $0 at both March 31, 2024 and December 31, 2023.

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 include 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 inputs (other than quoted prices) that are observable for the asset or liability, either directly or indirectly.

Level 3: Unobservable inputs that are supported by little or no market activities, which would require us to develop our own assumptions.

We classify 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 instruments 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 other 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 the 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 March 31, 2024 and December 31, 2023. Assets are classified in their entirety based on the 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)


	Fair Value Measurements as of
	March 31, 2024
	Estimated Fair Value		Level 1		Level 2		Level 3
Cash equivalents:
Money market funds	$	141,547	$	141,547	$	—	$	—


Total cash equivalents	141,547		141,547		—		—
Investments:
Commercial paper	5,394		—		5,394		—
Corporate debt securities	29,916		—		29,916		—
Certificates of deposit	10,647		—		10,647		—
Asset-backed securities	910		—		910		—
U.S. government securities	246,881		246,881		—		—
Total investments	293,748		246,881		46,867		—
Total cash equivalents and investments	$	435,295	$	388,428	$	46,867	$	—


	Fair Value Measurements as of
	December 31, 2023
	Estimated Fair Value		Level 1		Level 2		Level 3
Cash equivalents:
Money market funds	$	146,217	$	146,217	$	—	$	—

Total cash equivalents	146,217		146,217		—		—
Investments:
Commercial paper	2,951		—		2,951		—
Corporate debt securities	33,337		—		33,337		—
Certificates of deposit	2,968		—		2,968		—
Asset-backed securities	1,171		—		1,171		—
U.S. government securities	243,554		243,554		—		—
Total investments	283,981		243,554		40,427		—
Total cash equivalents and investments	$	430,198	$	389,771	$	40,427	$	—

There were no transfers between levels during the periods ended March 31, 2024 and December 31, 2023.

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 t

SEC Form 10-Q filed by Inspire Medical Systems Inc.