Inspire Medical Systems Inc
For the period ended Mar 31, 2025. Filed May 5, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 5, 2025
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Notes to Consolidated Financial Statements
Notes to Consolidated Financial Statements (Unaudited)
- 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"), European Union ("EU"), Medical Devices Regulation, and Japan Pharmaceuticals and Medical Devices Agency-approved neurostimulation technology of its kind that provides a safe and effective treatment for patients with moderate to severe OSA. Inspire therapy received premarket approval from the FDA in 2014 and has been commercially available in certain European markets since 2011 and certain Asia Pacific markets since 2021.
- Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial reporting and as required by the rules and regulations of the Securities and Exchange Commission. 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, 2024.
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 (income) expense, net in the consolidated statements of operations and comprehensive income (loss). For the three-month periods ended March 31, 2025 and 2024, we recognized $0.6 million of gain and $0.1 million of loss, net, respectively. Any unrealized gains and losses due to translation adjustments are included in accumulated other comprehensive income within stockholders' equity in the consolidated balance sheets. We had $0.1 million of unrecognized loss and $0.2 million of unrecognized gain in our accumulated other comprehensive income balance as of March 31, 2025 and December 31, 2024, respectively.
Investments
Our investments are classified as available-for-sale and consisted of the following:
| Amortized · Unrealized Gross · Aggregate | ||||
|---|---|---|---|---|
| Cost | Gains | Losses | Fair Value | |
| Short-Term: | ||||
| Commercial paper | $13,422 | $13 | $— | $13,435 |
| Corporate debt securities | 49,630 | 90 | (4) | 49,716 |
| Certificates of deposit | 2,994 | 5 | — | 2,999 |
| U.S. treasury debt securities | 249,016 | 179 | (38) | 249,157 |
| Short-term investments | $315,062 | $287 | $(42) | $315,307 |
| Long-Term: | ||||
| Corporate debt securities | $25,820 | $60 | $(13) | $25,867 |
| Asset-backed securities | 158 | — | — | 158 |
| U.S. treasury debt securities | 18,736 | 70 | — | 18,806 |
| Long-term investments | $44,714 | $130 | $(13) | $44,831 |
| Amortized · Unrealized Gross · Aggregate | ||||
|---|---|---|---|---|
| Cost | Gains | Losses | Fair Value | |
| Short-Term: | ||||
| Commercial paper | $19,806 | $25 | $— | $19,831 |
| Corporate debt securities | 47,226 | 80 | (7) | 47,299 |
| Certificates of deposit | 7,684 | 10 | — | 7,694 |
| U.S. treasury debt securities | 220,283 | 346 | (57) | 220,572 |
| Short-term investments | $294,999 | $461 | $(64) | $295,396 |
| Long-Term: | ||||
| Corporate debt securities | $23,915 | $59 | $(49) | $23,925 |
| Asset-backed securities | 287 | — | — | 287 |
| U.S. treasury debt securities | 46,818 | 50 | (85) | 46,783 |
| Long-term investments | $71,020 | $109 | $(134) | $70,995 |
The following table shows all available-for-sale investments in an unrealized loss position for which an allowance for credit losses has not been recorded and the related gross unrealized loss and fair value, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position:
| Less than 12 Months | 12 Months or Greater | Total | ||||
|---|---|---|---|---|---|---|
| Fair Value | Unrealized Loss | Fair Value | Unrealized Loss | Fair Value | Unrealized Loss | |
| Corporate debt securities | $10,593 | $(20) | $— | $— | $10,593 | $(20) |
| U.S. Treasury debt securities | 69,029 | (99) | — | — | 69,029 | (99) |
| Total | $79,622 | $(119) | $— | $— | $79,622 | $(119) |
| Less than 12 Months | 12 Months or Greater | Total | ||||
|---|---|---|---|---|---|---|
| Fair Value | Unrealized Loss | Fair Value | Unrealized Loss | Fair Value | Unrealized Loss | |
| Corporate debt securities | $11,728 | $(56) | $— | $— | $11,728 | $(56) |
| U.S. Treasury debt securities | 69,402 | (220) | — | — | 69,402 | (220) |
| Total | $81,130 | $(276) | $— | $— | $81,130 | $(276) |
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 income (loss) within stockholders' equity. We had $0.4 million of unrecognized gain in our accumulated other comprehensive income balance at both March 31, 2025 and December 31, 2024. 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 income (loss). We recognized $0 of gross realized gains and losses from the sale or maturity of available-for-sale investments during each of the three months ended March 31, 2025 and 2024, respectively.
As of March 31, 2025 and December 31, 2024, we hadno investments with a contractual maturity of greater than two 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 at maturity. We do not consider those investments to be other-than-temporarily impaired as of March 31, 2025. 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 in the consolidated statements of operations and comprehensive income (loss). The total allowance for credit losses was $0 at both March 31, 2025 and December 31, 2024.
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 debt 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 money market funds and available-for-sale securities are held bytwo custodians who obtain 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, 2025 and December 31, 2024. 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 of | ||||
|---|---|---|---|---|
| EstimatedFair Value | Level 1 | Level 2 | Level 3 | |
| Cash equivalents: | ||||
| Money market funds | $29,758 | $29,758 | $— | $— |
| Total cash equivalents | 29,758 | 29,758 | — | — |
| Investments: | ||||
| Commercial paper | 13,435 | — | 13,435 | — |
| Corporate debt securities | 75,583 | — | 75,583 | — |
| Certificates of deposit | 2,999 | — | 2,999 | — |
| Asset-backed securities | 158 | — | 158 | — |
| U.S. government securities | 267,963 | 267,963 | — | — |
| Total investments | 360,138 | 267,963 | 92,175 | — |
| Total cash equivalents and investments | $389,896 | $297,721 | $92,175 | $— |
| Fair Value Measurements as of | ||||
|---|---|---|---|---|
| EstimatedFair Value | Level 1 | Level 2 | Level 3 | |
| Cash equivalents: | ||||
| Money market funds | $59,606 | $59,606 | $— | $— |
| Total cash equivalents | 59,606 | 59,606 | — | — |
| Investments: | ||||
| Commercial paper | 19,831 | — | 19,831 | — |
| Corporate debt securities | 71,224 | — | 71,224 | — |
| Certificates of deposit | 7,694 | — | 7,694 | — |
| Asset-backed securities | 287 | — | 287 | — |
| U.S. government securities | 267,355 | 267,355 | — | — |
| Total investments | 366,391 | 267,355 | 99,036 | — |
| Total cash equivalents and investments | $425,997 | $326,961 | $99,036 | $— |
There were no transfers between levels during the periods ended March 31, 2025 and December 31, 2024.
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, 2025 and December 31, 2024, we limited our credit risk associated with cash equivalents by placing investments with banks we believe are highly creditworthy.
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).
The following table presents the changes in the allowance for credit losses related to accounts receivable:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Balance at beginning of period | $880 | $1,648 |
| Charges (credits) to the allowance, net | 444 | 76 |
| Accounts written off, net of recoveries | (133) | (1,468) |
| Balance at the end of the period | $1,191 | $256 |
The increase in accounts written off, net of recoveries during the three months ended March 31, 2024 are related primarily to accounts receivable withtwo healthcare systems.
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, 2025 | December 31, 2024 | |
|---|---|---|
| Raw materials | $24,016 | $22,430 |
| Work in process | 4,073 | — |
| Finished goods | 71,638 | 57,688 |
| Total inventories, net of reserves | $99,727 | $80,118 |
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. In August 2024, we received approval from the FDA for our next generation Inspire system, which we expect to fully launch in the U.S. in 2025.
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 $1.3 million and $1.0 million as of March 31, 2025 and December 31, 2024, respectively.
Property and Equipment
Property and equipment are stated at cost, less accumulated depreciation and amortization and consisted of the following:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Internal-use software | $17,231 | $16,553 |
| Manufacturing equipment | 44,949 | 29,117 |
| Other equipment | 5,259 | 4,981 |
| Leasehold improvements | 10,075 | 10,057 |
| Construction in process | 16,464 | 24,975 |
| Property and equipment, cost | 93,978 | 85,683 |
| Less: accumulated depreciation and amortization | (16,803) | (13,758) |
| Property and equipment, net | $77,175 | $71,925 |
Internal-use software costs are capitalized during the application development stage. Costs related to planning and post implementation activities are expensed as incurred. Capitalized internal-use software is amortized, and recognized as cost of goods sold or selling, general and administrative expenses, on a straight-line basis over the estimated useful life ofthree years. Construction in process is comprised primarily of manufacturing equipment. Depreciation is determined using the straight-line method over the estimated useful lives of the respective assets, generally three toten 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 $3.0 million and $0.8 million for the three months ended March 31, 2025 and 2024, 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 $11.2 million and $10.6 million as of March 31, 2025 and December 31, 2024, respectively. There wereno adjustments to the carrying amount during either of the three months ended March 31, 2025 or 2024.
Impairment of Long-lived Assets
Long-lived assets consist primarily of property and equipment, operating lease right-of-use assets, and strategic investments 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 didnot record any impairment charges on long-lived assets during either of the three months ended March 31, 2025 or 2024.
Accrued Expenses
Accrued expenses consisted of the following:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Payroll related | $25,385 | $40,162 |
| Income tax payable | 910 | 1,612 |
| Product warranty liability | 649 | 933 |
| Operating lease liabilities, current portion | 2,035 | 1,754 |
| Other accrued expenses | 5,354 | 5,353 |
| Total accrued expenses | $34,333 | $49,814 |
The following table shows the changes in our estimated product warranty liability accrual, included in accrued liabilities:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Balance at beginning of period | $933 | $1,100 |
| Provisions for warranty | (195) | 535 |
| Settlements of warranty claims | (89) | (247) |
| Balance at the end of the period | $649 | $1,388 |
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 8 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 manufacturing equipment, and operations and quality supervision and management personnel, including employee compensation, stock-based compensation, supplies, and travel.
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.
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-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 income (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 $20.9 million and $25.6 million during the three months ended March 31, 2025 and 2024, respectively.
Leases
Operating leases are included in operating lease right-of-use ("ROU") assets, accrued expenses, and operating lease liabilities – 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 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. We will continue to maintain a full valuation allowance until the point at which we are more certain than not that the deferred tax assets will be realized. Therefore, there is no provision for federal income taxes, but we do record provision for current state and foreign taxes, which includes a foreign tax reserve relating to uncertain tax positions. Our policy is to record interest and penalty expense related to uncertain tax positions as other expense in the consolidated statements of operations and comprehensive income (loss).
Comprehensive Income (Loss)
Comprehensive income (loss) consists of net income (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 is presented in the accompanying consolidated balance sheets as a component of stockholders' equity.
Income (Loss) Per Share
Basic net income (loss) per share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding during the period. Diluted net income (loss) per share is computed by dividing the net income (loss) by the weighted average number of shares of common stock and dilutive potential shares of common stock outstanding during the period. For the periods presented with a net loss, 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
In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures (“ASU 2023-09”). The guidance is intended to improve income tax disclosure requirements by requiring (i) consistent categories and greater disaggregation of information in the rate reconciliation and (ii) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the income tax disclosure requirements. The amendments in ASU 2023-09 are effective for us in fiscal 2025, with early adoption permitted, and is required to be applied prospectively with the option of retrospective application. We are evaluating the impact of the standard on our income tax disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income-Expense Disaggregation (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”). The guidance requires the disclosure of additional information related to certain costs and expenses, including amounts of inventory purchases, employee compensation, and depreciation and amortization included in each income statement line item. ASU 2024-03 also requires disclosure of the total amount of selling expenses and our definition of selling expenses. The ASU is effective for our annual reports beginning in fiscal 2027, and interim period reports beginning in fiscal 2028 either on a prospective or retrospective basis. Early adoption is permitted. We are currently evaluating the impact of adopting ASU 2024-03 on our financial statement disclosures.
We have reviewed and considered all other 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.
- Leases
We lease approximately 106,000 square feet of office space for our corporate headquarters under a noncancelable operating lease with a noncancelable lease term through May 31, 2035. In October 2024, we entered into an amendment on this lease which provides approximately 10,000 square feet of additional space.
We entered into an additional warehouse and office space lease for our corporate headquarters under a noncancelable operating lease in August 2023. This space includes approximately 22,000 square feet and a noncancelable lease term through May 31, 2035. In March 2024, we entered into an amendment on this lease which commenced in January 2025 which provides for approximately 18,000 square feet of additional space.
Each lease described above includes options to renew for up totwo additional periods offive years each at the then-prevailing market 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 as of the lease modification date as they were not reasonably certain of exercise.
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, 2025 | December 31, 2024 | |
|---|---|---|
| Right-of-use assets: | ||
| Operating lease right-of-use assets | $24,972 | $23,314 |
| Operating lease liabilities: | ||
| Accrued expenses | $2,035 | $1,754 |
| Operating lease liabilities, non-current portion | 31,488 | 30,039 |
| Total operating lease liabilities | $33,523 | $31,793 |
As of March 31, 2025, the remaining lease terms were 10.2 years and the weighted average discount rate was 4.9%. The operating cash outflows from our operating leases were $0.8 million and $0.6 million for the three-month periods ended March 31, 2025 and 2024, respectively.
- Employee Retirement Plan
We sponsor a defined contribution employee retirement plan covering all of our full-time employees. The plan allows eligible employees to defer a portion of their eligible compensation up to the maximum allowed by IRS Regulations. We make voluntary matching contributions of 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. Our matching contributions to the plan totaled $1.9 million and $1.5 million for the three months ended March 31, 2025 and 2024, respectively.
- Stockholders' Equity
Share Repurchase Program
In August 2024, our Board of Directors authorized the repurchase of up to $150.0 million of our outstanding shares of common stock from time to time through open market transactions, privately negotiated transactions, tender offers, or other means (the “share repurchase program”). We are not obligated to repurchase any specific number of shares and the program may be modified, suspended, or discontinued at any time. The share repurchase program will expire in August 2026, subject to the earlier termination or extension by the Board, in its sole discretion and without prior notice.
In November 2024, we entered into an accelerated share repurchase agreement (the “ASR Agreement”) with a large financial institution to repurchase common stock as part of the share repurchase program. Under the ASR Agreement, the financial institution delivered a portion of shares to us at contract inception and delivered the remaining shares at settlement. We made a prepayment of $75.0 million and received an initial delivery of 305,157 shares of common stock. We retired the initial shares delivered and recorded a $75.0 million reduction to additional paid-in capital. We accounted for the variable component of shares to be delivered under the ASR Agreement as a forward contract indexed to our common stock, which met the criteria for equity classification, and therefore, was accounted for as a component of equity.
In January 2025, we were notified of the early termination of the ASR Agreement. Upon final settlement in January 2025, we received an additional 103,886 shares of common stock from the financial institution. The final number of shares received was based on the volume-weighted average price of our common stock during the term of the ASR Agreement, less a discount and subject to adjustment pursuant to the terms of the ASR Agreement. The total shares repurchased under the ASR Agreement was 409,043 shares with the average share price of $190.29.
During the three-month period ended March 31, 2025, we purchased an additional 442,649 shares for $75.0 million under Rule 10b5-1 under the Company's share repurchase program. As of March 31, 2025, no amount remained available for future repurchases under the share repurchase program.
- Stock-Based Compensation
As of March 31, 2025, there were 4,868,700 shares reserved for issuance under our equity incentive plan, of which 1,411,756 shares were available for issuance.
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 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
Stock options are granted to employees at the exercise price, which is equal to the closing price of our stock on the date of grant. The stock options include afour-year service period and 25% vest after the first year of service and the remainder vest in equal monthly installments over the next 36 months of service. Unvested options are forfeitable in the event of termination other than for death, disability, or qualifying retirement. Upon death, disability or qualifying retirement, all outstanding and unvested options accelerate and become fully vested. The stock options have a contractual life often years.
The fair value per share of options is estimated on the date of grant using the Black-Scholes option pricing model. There wereno stock options granted during the three-month period ended March 31, 2025.
Option Value and Assumptions
| Three Months Ended | |
|---|---|
| March 31, | |
| Weighted average fair value | $124.70 |
| Assumptions: | |
| Expected term (years) | 6.25 |
| Expected volatility | 59.0 - 59.4% |
| Risk-free interest rate | 3.95 - 4.28% |
| Expected dividend yield | 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.
Expected Volatility— Beginning in 2024, we based expected volatility on the historic volatility of our common stock. Prior to 2024, due to our limited company specific historical and implied volatility data, we 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, 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.
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.
Stock Option Activity
| Options | Weighted AverageExercise Price | Weighted AverageRemainingContractual Term(years) | Aggregate IntrinsicValue (in thousands) | |
|---|---|---|---|---|
| Outstanding at December 31, 2024 | 2,160,149 | $168.33 | 6.4 | $89,052 |
| Granted | — | $— | ||
| Exercised | (73,672) | $87.27 | $7,795 | |
| Forfeited/expired | (28,264) | $226.31 | ||
| Outstanding at March 31, 2025 | 2,058,213 | $170.40 | 6.2 | $64,049 |
| Exercisable at March 31, 2025 | 1,609,096 | $155.50 | 5.7 | $63,444 |
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, 2025, the amount of unearned stock-based compensation currently estimated to be expensed from now through the year 2028 related to unvested stock options is $56.7 million, which we expect to recognize over a weighted average period of 2.0 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 in the event of termination other than for death, disability, or qualifying retirement. Upon death or disability, all outstanding and unvested RSUs accelerate and become fully vested and settled. Upon qualifying retirement, all outstanding and unvested RSUs remain outstanding and settle in accordance with the original vesting and payment terms applicable to such RSUs. The RSUs granted to employees include three- orfour-year service periods and vest in equal installments on each anniversary of the date of grant. The RSUs granted to the board of directors includeone- orthree-year service periods and vest in equal installments on each anniversary of the date of grant. 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 Units | Weighted AverageGrant Date Fair Value | Aggregate Intrinsic Value (in thousands) | |
|---|---|---|---|
| Unvested at December 31, 2024 | 679,905 | $195.63 | $126,041 |
| Granted | 513,378 | $186.96 | |
| Vested | (160,612) | $208.10 | $29,174 |
| Forfeited | (18,781) | $192.18 | |
| Unvested at March 31, 2025 | 1,013,890 | $189.31 | $161,492 |
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 award vesting. As of March 31, 2025, the amount of unearned stock-based compensation currently estimated to be expensed from now through the year 2028 related to unvested RSUs was $171.9 million which we expect to recognize over a weighted average period of 2.4 years.
Performance Stock Units
We grant 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 respective three-year periods from the date of grant. 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 are assessed each reporting period. The number of shares earned at the end of each of thethree-year periods will vary 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 grant will be reversed. PSUs are subject to forfeiture in the event of termination other than a termination due to death, disability, or qualifying retirement occurring after the first 12 months of the applicable performance period. Upon such a termination due to death or disability, a prorated amount of the target number of PSUs will accelerate and become fully vested. Upon such a qualifying retirement, a prorated amount of the PSUs will be eligible to vest and settle based on the actual performance achievement in accordance with the original vesting and payment terms applicable to such PSUs.
A summary of PSUs and related information is as follows:
| Performance Stock Units | Weighted AverageGrant Date Fair Value | Aggregate Intrinsic Value (in thousands) | |
|---|---|---|---|
| Unvested at December 31, 2024 | 323,302 | $220.82 | $59,934 |
| Granted | 236,333 | $199.70 | |
| Vested | (143,518) | $228.48 | $26,759 |
| Forfeited | (18,921) | $224.92 | |
| Unvested at March 31, 2025 | 397,196 | $205.37 | $63,265 |
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, 2025, there was $61.5 million of unrecognized stock-based compensation expense related to outstanding PSUs that is expected to be recognized over a weighted-average period of 2.1 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 1,384,440 shares available for future issuance under the ESPP as of March 31, 2025. The current purchase period under the ESPP began on January 1, 2025 and ends June 30, 2025.
- Income Taxes
At both March 31, 2025 and December 31, 2024, a valuation allowance was recorded against all deferred tax assets due to our cumulative net loss position. We recorded income tax expense of $1.2 million and $0.7 million for the three months ended March 31, 2025 and 2024, respectively. The income tax expense reflects state and foreign income tax expense in both of the three months ended March 31, 2025 and March 31, 2024.
As of December 31, 2024, we had gross federal net operating loss carryforwards, which are no longer subject to expiration, of $51.2 million. In addition, we had net operating loss carryforwards for state income tax purposes of $88.0 million which will begin to expire in 2025. We also have gross R&D credit carryforwards of $13.4 million as of December 31, 2024, which will expire at various dates beginning in 2034.
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 Code and similar state provisions. During 2025, we finalized an updated analysis to determine whether an ownership change has occurred through December 31, 2024, 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 of federal net operating losses nor the $1.7 million of federal R&D credits that were accumulated on December 11, 2018 will expire unused solely due to the limitations under Sections 382 and 383 of the Code.
Realization of the deferred tax assets is dependent upon the generation of future book income, if any, the amount and timing of which are uncertain. Based on available objective evidence and cumulative losses, we believe it is 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 tax payable on unrecognized tax positions as of both March 31, 2025 and December 31, 2024.
We file income tax returns in the applicable jurisdictions. The 2020 to 2023 tax years remain open to examination by the major taxing authorities to which we are subject. We donot expect a significant change to our unrecognized tax positions over the next 12 months.
- Segment Reporting and Revenue Disaggregation
We operate our business asone 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 ("CODM") in deciding how to allocate resources and in assessing performance. Our CODM is the Company's President, Chief Executive Officer, and Chair of the Board of Directors. Reportable segment information is consistent with how management reviews the business, makes investing and resource allocation decisions and assesses operating performance. Our segment revenues are derived from the sales of our product, the Inspire system, to hospitals and ambulatory surgery centers in the U.S. and in select countries in Europe and the Asia Pacific region. We do not have any intra-entity sales or transfers.
Our CODM uses consolidated net income (loss) as the measure of profit or loss. Our CODM assesses performance for the segment and allocates resources and monitors budget versus actual results using consolidated net income (loss) and operating income (loss). The monitoring of budget versus actual results are used in establishing management's compensation. The measure of segment assets is reported on the balance sheet as total consolidated assets.
| Three Months Ended | ||
|---|---|---|
| March 31, | ||
| 2025 | 2024 | |
| Revenue | $201,317 | $164,010 |
| Less: (a) | ||
| Cost of goods sold | 30,709 | 24,757 |
| Research and development expense | 27,803 | 28,850 |
| Selling, general and administrative expense (excluding advertising expense) | 123,349 | 100,018 |
| Advertising expense | 20,941 | 25,603 |
| Operating loss | (1,485) | (15,218) |
| Other income (b) | (5,644) | (5,863) |
| Income taxes | 1,167 | 650 |
| Segment net income (loss) | 2,992 | (10,005) |
| Reconciliation of profit or loss | ||
| Adjustments and reconciling items | — | — |
| Consolidated net income (loss) | $2,992 | $(10,005) |
(a) The significant expense categories and amounts align with the segment-level information that is regularly provided to our chief operating decision maker.
(b) Other income represents the consolidated amounts for interest and dividend income, interest expense, and other expense, net, as shown on our consolidated statements of operations and comprehensive income (loss).
For the three-month periods ended March 31, 2025 and 2024, depreciation and amortization expense was $3.0 million and $0.8 million, respectively, and is included within the segment expense captions of cost of goods sold, research and development expense, and selling, general and administrative ("SG&A") expense.
For the three-month periods ended March 31, 2025 and 2024, stock-based compensation expense was $31.1 million and $26.3 million, respectively, and is included within the segment expense captions of cost of goods sold, research and development expense, and SG&A expense.
Revenue by geographic region is as follows:
| Three Months Ended | ||
|---|---|---|
| March 31, | ||
| 2025 | 2024 | |
| United States | $193,606 | $155,771 |
| All other countries | 7,711 | 8,239 |
| Total revenue | $201,317 | $164,010 |
Long-lived tangible assets by geographic location were as follows:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| United States | $76,288 | $71,008 |
| All other countries | 887 | 917 |
| Total long-lived tangible assets | $77,175 | $71,925 |
- Income (Loss) Per Share
Basic net income (loss) per share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding during the period. Diluted net income (loss) per share is computed by dividing the net income (loss) by the weighted average number of shares of common stock and dilutive potential shares of common stock outstanding during the period. For the periods presented with a net loss, 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 components of net income (loss) per share are as follows:
| Three Months Ended | ||
|---|---|---|
| March 31, | ||
| 2025 | 2024 | |
| Numerator: | ||
| Net income (loss) | $2,992 | $(10,005) |
| Denominator: | ||
| Weighted average number of common shares outstanding - basic | 29,702,358 | 29,615,166 |
| Dilutive effect of stock options | 441,165 | — |
| Dilutive effect of restricted stock units | 157,476 | — |
| Dilutive effect of shares issuable under the ESPP | 10,477 | — |
| Weighted average number of common shares outstanding - diluted | 30,311,476 | 29,615,166 |
| Net income (loss) per share: | ||
| Basic | $0.10 | $(0.34) |
| Diluted | $0.10 | $(0.34) |
The following common stock-based awards were excluded from the computation of diluted net income (loss) per common share for the periods presented because including them would have been antidilutive:
| March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Stock options | 1,450,239 | 2,501,573 |
| Restricted stock units | 301,153 | 554,614 |
| Shares issuable under the ESPP | — | 5,872 |
| Total | 1,751,392 | 3,062,059 |
- Related Party Transaction
In December 2023, we entered into an agreement with an entity controlled by our Chief Executive Officer (the "Entity"), pursuant to which we agreed to share the costs of a corporate suite at a sports and entertainment venue (the "Venue") (the “Suite”) (the “Cost Sharing Agreement”). In August 2023, the Entity entered into an agreement with the Venue, pursuant to which the Entity acquired certain rights to use the Suite for specified sporting and other events at the Venue through August 2026. Pursuant to this agreement, the Entity agreed to pay $0.2 million per year, with each year beginning September 1 and ending August 31, and the fee increasing by 5% for each succeeding year. Under the Cost Sharing Agreement, we will reimburse the Entity 50% of the cost of the Suite in exchange for the right to use the Suite for 50% of the specified events at the Venue through August 2026. We recognized expense of less than $0.1 million for the use of the suite in SG&A expense in our consolidated statements of operations and comprehensive income (loss) during each of the three months ended March 31, 2025 and 2024, respectively.
- Commitments and Contingencies
We are involved in claims and litigation in the ordinary course of business, some of which seek monetary damages, including claims for punitive damages, which may not be covered by insurance. We evaluate all matters and record liabilities for losses from legal proceedings when we determine that it is probable that the outcome will be unfavorable and the amount, or potential range, of loss can be reasonably estimated. An adverse determination in one or more of these pending matters could have an adverse effect on our consolidated financial position, results of operations or cash flows.
As previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, Inspire andtwo of its executive officers were named as defendants in a purported federal securities law class action filed in the United States District Court for the District of Minnesota, captioned City of Hollywood Firefighters’ Pension Fund v. Inspire Medical Systems, Inc., et. al., Court File No. 0:23-cv-03884 (the "City of Hollywood Lawsuit"). The plaintiff filed an amended complaint on April 19, 2024, which alleged violations of Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5, which alleged violations related to certain prior disclosures of Inspire about the effectiveness of a program intended to help certain customers establish independence in seeking prior authorization from payors for our Inspire therapy. The plaintiff sought to represent a class of shareholders who purchased or otherwise acquired Inspire common stock between May 3, 2023 and November 7, 2023. On June 28, 2024, the defendants moved to dismiss the amended complaint in its entirety. On March 24, 2025, the Court granted defendants' motion to dismiss, and dismissed the amended complaint with prejudice. The dismissal is now final.
On July 16, 2024, a stockholder derivative lawsuit was filed in the United States District Court for the District of Minnesota, purportedly on behalf of Inspire against certain of our present and former officers and directors and Inspire (as a nominal defendant), captioned Lawrence Hollin v. Herbert, et al., Court File No. 0:24-cv-02716 (the “Hollin Lawsuit”). The Hollin Lawsuit arose out of the same subject matter as the City of Hollywood Lawsuit and alleged the following claims under common law and the Exchange Act: (1) breach of fiduciary duty; (2) unjust enrichment; (3) waste of corporate assets; and (4) as against the officer defendants, contribution under Sections
10(b) and 21D of the Exchange Act. The lawsuit sought unspecified damages. On September 5, 2024, counsel for Mr. Hollin filed a motion for voluntary dismissal of the Hollin Lawsuit, which motion remains pending.
In addition, on January 17, 2025, we received a civil investigative demand (“CID”) from the Department of Justice U.S. Attorney’s Office for the District of Minnesota pursuant to the False Claims Act in the course of the government’s investigation concerning allegations of false claims, including false claims arising from violations of the Anti-Kickback Statute, submitted to government payors in connection with our implant. The CID requests information relating to the marketing, promotion, and reimbursement practices associated with our products. We are cooperating with the investigation. No assurance can be given as to the timing or outcome of the government’s investigation.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.