PODD 10-Q
Insulet Corp (PODD)
10-Q
2025-11-06
For: 2025-09-30
View Original
Added on
April 08, 2026
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________________________________________
Form 10-Q
_____________________________________________________
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
For the quarterly period ended September 30, 2025
OR
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
Commission File Number 001-33462
___________________________________________________________
(Exact name of Registrant as specified in its charter)
__________________________________________________________________________________________________
| (State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) | ||||||||||||||||
| (Address of Principal Executive Offices) | (Zip Code) | ||||||||||||||||
Registrant’s Telephone Number, Including Area Code: (978 ) 600-7000
________________________________________________________________________________________________________
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.
| ☒ | 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 ☒
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
As of October 30, 2025, the registrant had 70,346,898 shares of common stock outstanding.
TABLE OF CONTENTS
Condensed Consolidated Balance Sheets (Unaudited) as of September 30, 2025 and December 31, 2024 | |||||
Condensed Consolidated Statements of Income (Unaudited) for the three and nine months ended September 30, 2025 and 2024 | |||||
Condensed Consolidated Statements of Comprehensive Income (Unaudited) for the three and nine months ended September 30, 2025 and 2024 | |||||
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) for the three and nine months ended September 30, 2025 and 2024 | |||||
Condensed Consolidated Statements of Cash Flows (Unaudited) for the nine months ended September 30, 2025 and 2024 | |||||
PART I - FINANCIAL INFORMATION
Item 1. | Condensed Consolidated Financial Statements (Unaudited) | ||||
INSULET CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
| (in millions, except share and per share data) | September 30, 2025 | December 31, 2024 | |||||||||
| ASSETS | |||||||||||
| Current Assets | |||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
Accounts receivable trade, net of allowance for credit losses of $ | |||||||||||
| Accounts receivable trade, net — related party | |||||||||||
| Inventories | |||||||||||
Prepaid expenses | |||||||||||
Other current assets | |||||||||||
| Total current assets | |||||||||||
| Property, plant and equipment, net | |||||||||||
| Other intangible assets, net | |||||||||||
| Goodwill | |||||||||||
Deferred tax assets | |||||||||||
Other assets | |||||||||||
| Total assets | $ | $ | |||||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
| Current Liabilities | |||||||||||
| Accounts payable | $ | $ | |||||||||
| Accrued expenses and other current liabilities | |||||||||||
| Accrued expenses and other current liabilities — related party | |||||||||||
| Current portion of long-term debt | |||||||||||
| Total current liabilities | |||||||||||
| Long-term debt, net | |||||||||||
| Other liabilities | |||||||||||
| Total liabilities | |||||||||||
Commitments and contingencies (note 12) | |||||||||||
| Stockholders’ Equity | |||||||||||
Preferred stock, $ | |||||||||||
Common stock, $ | |||||||||||
| Additional paid-in capital | |||||||||||
Accumulated earnings | |||||||||||
Accumulated other comprehensive income (loss) | ( | ||||||||||
Treasury stock, at cost; | ( | ||||||||||
Deferred compensation | |||||||||||
| Total stockholders’ equity | |||||||||||
| Total liabilities and stockholders’ equity | $ | $ | |||||||||
See notes to condensed consolidated financial statements. Amounts may not add due to rounding.
3
INSULET CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(UNAUDITED)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| (in millions, except share and per share data) | 2025 | 2024 | 2025 | 2024 | |||||||||||||||||||
| Revenue | $ | $ | $ | $ | |||||||||||||||||||
| Revenue from related party | |||||||||||||||||||||||
| Total revenue | |||||||||||||||||||||||
| Cost of revenue | |||||||||||||||||||||||
| Gross profit | |||||||||||||||||||||||
| Research and development expenses | |||||||||||||||||||||||
| Selling, general and administrative expenses | |||||||||||||||||||||||
Operating income | |||||||||||||||||||||||
Interest expense | ( | ( | ( | ( | |||||||||||||||||||
Interest income | |||||||||||||||||||||||
Loss on extinguishment of debt | ( | ||||||||||||||||||||||
| Other income (expense), net | ( | ( | |||||||||||||||||||||
Income before income taxes | |||||||||||||||||||||||
Income tax (expense) benefit | ( | ( | ( | ||||||||||||||||||||
Net income | $ | $ | $ | $ | |||||||||||||||||||
Earnings per share: | |||||||||||||||||||||||
| Basic | $ | $ | $ | $ | |||||||||||||||||||
| Diluted | $ | $ | $ | $ | |||||||||||||||||||
Weighted-average number of common shares outstanding (in thousands): | |||||||||||||||||||||||
| Basic | |||||||||||||||||||||||
| Diluted | |||||||||||||||||||||||
See notes to condensed consolidated financial statements. Amounts may not add due to rounding.
4
INSULET CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(UNAUDITED)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| (in millions) | 2025 | 2024 | 2025 | 2024 | |||||||||||||||||||
| Net income | $ | $ | $ | $ | |||||||||||||||||||
| Other comprehensive income (loss), net of tax: | |||||||||||||||||||||||
| Foreign currency translation adjustment | ( | ||||||||||||||||||||||
Unrealized gain (loss) on cash flow hedges, net of tax | ( | ( | ( | ||||||||||||||||||||
Other comprehensive (loss) income, net of tax | ( | ||||||||||||||||||||||
| Comprehensive income | $ | $ | $ | $ | |||||||||||||||||||
See notes to condensed consolidated financial statements. Amounts may not add due to rounding.
5
INSULET CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(UNAUDITED)
Three Months Ended September 30, 2025
| Common Stock | Additional Paid-in Capital | Accumulated Earnings | Accumulated Other Comprehensive Income | Treasury Stock | Deferred Compensation | Total Shareholders’ Equity | |||||||||||||||||||||||||||||||||||||||||
| (dollars in millions) | Shares (in thousands) | Amount | |||||||||||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2025 | $ | $ | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||||||||||||
| Net income | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Other comprehensive loss, net of tax | — | — | — | — | ( | — | — | ( | |||||||||||||||||||||||||||||||||||||||
| Exercise of options to purchase common stock | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Restricted stock units vested, net of shares withheld for taxes | — | ( | — | — | — | — | ( | ||||||||||||||||||||||||||||||||||||||||
| Repurchase of common stock | ( | — | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||||||||||||
| Conversion of Convertible Senior Notes | — | — | ( | — | — | — | — | ( | |||||||||||||||||||||||||||||||||||||||
| Settlement of capped call options | — | — | ( | — | — | — | — | ( | |||||||||||||||||||||||||||||||||||||||
| Balance at September 30, 2025 | $ | $ | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||||||||||||
Three Months Ended September 30, 2024
| Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive (Loss) Income | Total Shareholders’ Equity | |||||||||||||||||||||||||||||||
| (dollars in millions) | Shares (in thousands) | Amount | |||||||||||||||||||||||||||||||||
| Balance at June 30, 2024 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
| Net income | — | — | — | — | |||||||||||||||||||||||||||||||
| Other comprehensive income, net of tax | — | — | — | — | |||||||||||||||||||||||||||||||
| Exercise of options to purchase common stock | — | — | — | ||||||||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | — | — | |||||||||||||||||||||||||||||||
| Restricted stock units vested, net of shares withheld for taxes | — | ( | — | — | ( | ||||||||||||||||||||||||||||||
| Balance at September 30, 2024 | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||
See notes to condensed consolidated financial statements. Amounts may not add due to rounding.
6
Nine Months Ended September 30, 2025
| Common Stock | Additional Paid-in Capital | Accumulated Earnings | Accumulated Other Comprehensive (Loss) income | Treasury Stock | Deferred Compensation | Total Shareholders’ Equity | |||||||||||||||||||||||||||||||||||||||||
| (dollars in millions) | Shares (in thousands) | Amount | |||||||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | $ | ( | $ | $ | $ | |||||||||||||||||||||||||||||||||||||||
| Net income | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income, net of tax | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Exercise of options to purchase common stock | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Issuance of shares for employee stock purchase plan | — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Restricted stock units vested, net of shares withheld for taxes | — | ( | — | — | — | — | ( | ||||||||||||||||||||||||||||||||||||||||
| Repurchase of common stock | ( | — | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||||||||||||
Deferred compensation | — | — | — | — | — | ( | |||||||||||||||||||||||||||||||||||||||||
| Conversion of Convertible Senior Notes | — | — | ( | — | — | — | — | ( | |||||||||||||||||||||||||||||||||||||||
| Settlement of capped call options | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
| Balance at September 30, 2025 | $ | $ | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||||||||||||
Nine Months Ended September 30, 2024
| Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | Total Shareholders’ Equity | |||||||||||||||||||||||||||||||
| (dollars in millions) | Shares (in thousands) | Amount | |||||||||||||||||||||||||||||||||
| Balance at December 31, 2023 | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||
| Net income | — | — | — | — | |||||||||||||||||||||||||||||||
| Other comprehensive income, net of tax | — | — | — | — | |||||||||||||||||||||||||||||||
| Exercise of options to purchase common stock | — | — | — | ||||||||||||||||||||||||||||||||
| Issuance of shares for employee stock purchase plan | — | — | — | ||||||||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | — | — | |||||||||||||||||||||||||||||||
| Restricted stock units vested, net of shares withheld for taxes | — | ( | — | — | ( | ||||||||||||||||||||||||||||||
| Balance at September 30, 2024 | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||
See notes to condensed consolidated financial statements. Amounts may not add due to rounding.
7
INSULET CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
Nine Months Ended September 30, | |||||||||||
| (in millions) | 2025 | 2024 | |||||||||
| Cash flows from operating activities | |||||||||||
| Net income | $ | $ | |||||||||
| Adjustments to reconcile net income to net cash provided by operating activities: | |||||||||||
| Depreciation and amortization | |||||||||||
| Stock-based compensation expense | |||||||||||
| Non-cash interest expense | |||||||||||
| Loss on extinguishment of debt | |||||||||||
| Gain on derivative asset | ( | ||||||||||
Deferred income taxes | ( | ||||||||||
Provisions for credit losses | |||||||||||
Unrealized loss on investments | |||||||||||
| Other | |||||||||||
| Changes in operating assets and liabilities: | |||||||||||
| Accounts receivable | ( | ( | |||||||||
| Accounts receivable — related party | ( | ||||||||||
| Inventories | ( | ( | |||||||||
| Prepaid expenses and other assets | ( | ( | |||||||||
| Accounts payable | |||||||||||
| Accrued expenses and other liabilities | |||||||||||
| Accrued expenses and other liabilities — related party | ( | ||||||||||
| Net cash provided by operating activities | |||||||||||
| Cash flows from investing activities | |||||||||||
| Capital expenditures | ( | ( | |||||||||
| Investments in developed software | ( | ( | |||||||||
| Cash paid for investments | ( | ||||||||||
| Net cash used in investing activities | ( | ( | |||||||||
| Cash flows from financing activities | |||||||||||
Proceeds from issuance of senior unsecured notes, net of issuance costs | |||||||||||
Repayment of convertible debt | ( | ||||||||||
Settlement of capped call options | |||||||||||
Proceeds from issuance of term loan B, net of issuance costs | |||||||||||
| Repayment of term loan B | ( | ( | |||||||||
| Repayment of equipment financings | ( | ( | |||||||||
| Financing lease repayments | ( | ||||||||||
| Repayment of mortgage | ( | ( | |||||||||
Proceeds from secured borrowing (note 3) | |||||||||||
Repayment of secured borrowing (note 3) | ( | ( | |||||||||
Repurchase of common stock | ( | ||||||||||
| Proceeds from exercise of stock options | |||||||||||
| Proceeds from issuance of common stock under employee stock purchase plan | |||||||||||
| Payment of withholding taxes in connection with vesting of restricted stock units | ( | ( | |||||||||
Net cash used in financing activities | ( | ( | |||||||||
| Effect of exchange rate changes on cash and cash equivalents | |||||||||||
Net (decrease) increase in cash and cash equivalents | ( | ||||||||||
Cash and cash equivalents at beginning of period | |||||||||||
Cash and cash equivalents at end of period | $ | $ | |||||||||
| Supplemental noncash information: | |||||||||||
| Purchases of property and equipment included in accounts payable and accrued expenses | $ | $ | |||||||||
| Purchases of property, plant and equipment included in long-term debt | $ | $ | |||||||||
Additions to right-of-use assets resulting from new operating lease liabilities | $ | $ | |||||||||
See notes to condensed consolidated financial statements. Amounts may not add due to rounding.
8
INSULET CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 1. Basis of Presentation and Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited financial statements reflect the consolidated income of Insulet Corporation and its subsidiaries (“Insulet” or the “Company”). The unaudited condensed financial statements have been prepared in United States dollars, in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The preparation of the consolidated financial statements in conformity with GAAP requires management to make use of estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities, and the reported amounts of revenues and expenses. Actual results may differ from those estimates. In management’s opinion, the unaudited condensed financial statements contain all normal recurring adjustments necessary for a fair statement of the interim results reported. Operating results for the nine months ended September 30, 2025 are not necessarily indicative of the results that may be expected for the full year ending December 31, 2025, or for any other subsequent interim period. Columns and rows within tables may not add due to rounding.
The year-end balance sheet data was derived from the audited consolidated financial statements. These unaudited condensed financial statements do not include all of the annual disclosures required by GAAP; accordingly, they should be read in conjunction with the Company’s audited consolidated financial statements contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.
Related Party Transactions
One of the members of the Company’s Board of Directors was married to an executive officer of one of the Company’s distributors. The terms of the distribution agreement are consistent with those prevailing at arm’s length.
Shipping and Handling Costs
Advertising Costs
Advertising costs were $49.0 million and $28.3 million for the three months ended September 30, 2025 and 2024, respectively, and were $86.7 million and $60.2 million for the nine months ended September 30, 2025 and 2024, respectively. Advertising costs are included in selling, general and administrative expenses.
Fair Value Measurements
Fair value is defined as the price that would be received from the sale of an asset or paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date. To measure fair value of assets and liabilities, the Company uses the following fair value hierarchy based on three levels of input:
Level 1—observable inputs, such as quoted prices in active markets for identical assets or liabilities;
Level 2—significant other observable inputs that are observable either directly or indirectly; and
Level 3—significant unobservable inputs for which there are little or no market data, which require the Company to develop its own assumptions.
Judgment is involved in estimating inputs, such as discount rates, used in Level 3 fair value measurements. Changes to these inputs can have a significant effect on fair value measurements and amounts that could be realized.
Certain of the Company’s financial instruments, including cash and cash equivalents, accounts receivable, accounts payable, accrued expenses and other liabilities, are carried at cost, which approximates their fair value because of their short-term maturity.
9
Note 2. Revenue and Contract Acquisition Costs
The following table summarizes the Company’s disaggregated revenue:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| (in millions) | 2025 | 2024 | 2025 | 2024 | |||||||||||||||||||
U.S. | $ | $ | $ | $ | |||||||||||||||||||
International | |||||||||||||||||||||||
Total Omnipod products | |||||||||||||||||||||||
| Drug Delivery | |||||||||||||||||||||||
| Total revenue | $ | $ | $ | $ | |||||||||||||||||||
The percentages of total revenue for customers that represent 10% or more of total revenue were as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Distributor A | % | % | % | % | |||||||||||||||||||
| Distributor B | % | % | % | % | |||||||||||||||||||
Distributor C | % | % | % | % | |||||||||||||||||||
Deferred revenue related to unsatisfied performance obligations was included in the following consolidated balance sheet accounts in the amounts shown:
(in millions) | September 30, 2025 | December 31, 2024 | |||||||||
| Accrued expenses and other current liabilities | $ | $ | |||||||||
| Other liabilities | |||||||||||
| Total deferred revenue | $ | $ | |||||||||
Revenue recognized from amounts included in deferred revenue at the beginning of each respective period was as follows:
| Nine Months Ended September 30, | ||||||||||||||
| (in millions) | 2025 | 2024 | ||||||||||||
| Deferred revenue recognized | $ | $ | ||||||||||||
Contract acquisition costs, representing capitalized commission costs related to new customers, net of amortization, were included in the following consolidated balance sheet captions in the amounts shown:
| (in millions) | September 30, 2025 | December 31, 2024 | |||||||||
| Prepaid expenses and other current assets | $ | $ | |||||||||
| Other assets | |||||||||||
| Total capitalized contract acquisition costs, net | $ | $ | |||||||||
The Company recognized $5.9 million and $4.6 million of amortization of capitalized contract acquisition costs during the three months ended September 30, 2025 and 2024, respectively, and recognized $16.5 million and $13.2 million of amortization of capitalized contract acquisition costs during the nine months ended September 30, 2025 and 2024, respectively.
Note 3. Accounts Receivable, Net
Accounts receivable, net were comprised of the following:
| (in millions) | September 30, 2025 | December 31, 2024 | |||||||||
| Accounts receivable trade, net | $ | $ | |||||||||
| Unbilled receivable | |||||||||||
| Accounts receivable, net | $ | $ | |||||||||
10
The percentages of accounts receivable trade for customers that represent 10% or more of total accounts receivable trade were as follows:
| September 30, 2025 | December 31, 2024 | ||||||||||
| Distributor A | % | % | |||||||||
| Distributor B | % | % | |||||||||
Distributor C | % | % | |||||||||
Note 4. Inventories
Inventories were comprised of the following:
| (in millions) | September 30, 2025 | December 31, 2024 | |||||||||
| Raw materials | $ | $ | |||||||||
| Work in process | |||||||||||
| Finished goods | |||||||||||
| Total inventories | $ | $ | |||||||||
Following the strategic decision to not move forward with the commercialization of Omnipod GO, the Company recorded a charge of $13.5 million related to certain inventory components that it no longer expected to utilize, which is included in cost of revenue in the consolidated statements of income for the nine months ended September 30, 2024.
Note 5. Cloud Computing Costs
Capitalized costs to implement cloud computing arrangements at cost and accumulated amortization were as follows:
| (in millions) | September 30, 2025 | December 31, 2024 | |||||||||
| Short-term portion | $ | $ | |||||||||
| Long-term portion | |||||||||||
| Total capitalized implementation costs | |||||||||||
| Less: accumulated amortization | ( | ( | |||||||||
| Capitalized implementation costs, net | $ | $ | |||||||||
Amortization expense was $8.4 million and $6.9 million for the three months ended September 30, 2025 and 2024, respectively, and was $23.9 million and $19.5 million for the nine months ended September 30, 2025 and 2024, respectively.
Note 6. Goodwill and Other Intangible Assets, Net
The change in the carrying amount of goodwill was as follows:
| (in millions) | |||||
Balance at December 31, 2024 | $ | ||||
Foreign currency translation | |||||
Balance at September 30, 2025 | $ | ||||
11
The gross carrying amount, accumulated amortization and net book value of intangible assets at the end of each period were as follows:
| September 30, 2025 | December 31, 2024 | ||||||||||||||||||||||||||||||||||
(in millions) | Gross Carrying Amount | Accumulated Amortization | Net Book Value | Gross Carrying Amount | Accumulated Amortization | Net Book Value | |||||||||||||||||||||||||||||
| Customer relationships | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||
| Internal-use software | ( | ( | |||||||||||||||||||||||||||||||||
| Developed technology | ( | ( | |||||||||||||||||||||||||||||||||
| Patents | ( | ( | |||||||||||||||||||||||||||||||||
| Total intangible assets | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||
Amortization expense for intangible assets was $2.7 million and $2.5 million for the three months ended September 30, 2025 and 2024, respectively, and was $7.7 million and $7.3 million for the nine months ended September 30, 2025 and 2024, respectively.
Note 7. Investments
Equity Securities Measured at Fair Value on a Non-Recurring Basis
The total carrying value of the Company’s investments in equity securities without readily determinable fair values was $19.1 million and $21.9 million as of September 30, 2025 and December 31, 2024, respectively, and was included within other assets on the consolidated balance sheets. These investments are carried at cost less impairment, if any. If an observable price change in orderly transactions for the identical or similar investment in the same issuer is identified, the investments are measured at fair value as of the date that the observable transaction occurred and categorized as Level 2 in the fair value hierarchy. The Company recorded a $2.8 million impairment associated with one equity security during the nine months ended September 30, 2025, which is included in other income (expense), net. There was no 0.8
Debt Securities
Note 8. Accrued Expenses and Other Current Liabilities
The components of accrued expenses and other current liabilities were as follows:
| (in millions) | September 30, 2025 | December 31, 2024 | |||||||||
| Accrued rebates | $ | $ | |||||||||
| Employee compensation and related costs | |||||||||||
| Professional and consulting services | |||||||||||
| Other | |||||||||||
| Accrued expenses and other current liabilities | $ | $ | |||||||||
Product Warranty Costs
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Reconciliations of the changes in the Company’s product warranty liability were as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| (in millions) | 2025 | 2024 | 2025 | 2024 | |||||||||||||||||||
| Product warranty liability at beginning of period | $ | $ | $ | $ | |||||||||||||||||||
| Warranty expense | |||||||||||||||||||||||
Change in estimate | ( | ||||||||||||||||||||||
| Warranty fulfillment | ( | ( | ( | ( | |||||||||||||||||||
| Product warranty liability at the end of period | $ | $ | $ | $ | |||||||||||||||||||
Note 9. Debt
The components of debt consisted of the following:
| September 30, 2025 | December 31, 2024 | ||||||||||||||||
(in millions) | Maturity Date | Amount | Amount | ||||||||||||||
Equipment financing | 2025 | ||||||||||||||||
Mortgage | 2025 | ||||||||||||||||
Convertible Senior Notes | 2026 | ||||||||||||||||
Equipment financings | 2028 | ||||||||||||||||
| Revolving Credit Facility | 2030 | ||||||||||||||||
Term Loan B | 2031 | ||||||||||||||||
Senior Unsecured Notes | 2033 | ||||||||||||||||
| Unamortized debt discount | 2025 - 2033 | ( | ( | ||||||||||||||
| Debt issuance costs | 2025 - 2033 | ( | ( | ||||||||||||||
| Total debt, net | |||||||||||||||||
| Less: current portion | |||||||||||||||||
| Total long-term debt, net | $ | $ | |||||||||||||||
Convertible Senior Notes
During the three months ended September 30, 2025, the Company paid $510.7 million in cash to redeem all of the remaining 0.375 % Convertible Senior Notes due September 2026 (the “Convertible Notes”) that were previously outstanding. The difference between the cash paid and the $380.1 million aggregate principal amount outstanding ($378.5 million net of issuance costs) upon conversion was recorded to additional paid in capital. During the nine months ended September 30, 2025, the Company repurchased all outstanding Convertible Notes ($796.0 million net of issuance costs) for $1,052.2 million in cash, which resulted in a $123.9 million loss on extinguishment and a $132.3 million decrease to additional paid in capital for the portion that was converted. Additionally, during the three and nine months ended September 30, 2025, the Company received proceeds from the settlement of capped calls options totaling $88.9 million and $164.6 million, respectively.
The Company’s Convertible Notes had an effective interest rate of 1.25 %. The components of interest expense related to the Convertible Notes were as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
(in millions) | 2025 | 2024 | 2025 | 2024 | |||||||||||||||||||
Contractual interest expense | $ | $ | $ | $ | |||||||||||||||||||
Amortization of debt issuance costs | |||||||||||||||||||||||
Total interest recognized on the Convertible Notes | $ | $ | $ | $ | |||||||||||||||||||
Senior Secured Credit Agreement
In March 2025, the Company upsized the borrowing capacity under its Revolving Credit Facility to $500 million and extended the maturity date to March 2030.
In June 2025, the Company amended its Term Loan B to bear interest at a rate of Secured Overnight Financing Rate (“SOFR”) plus 2.00 %. At the same time, the Company amended its Revolving Credit Facility such that borrowings bear interest at a rate of SOFR plus an applicable margin of 1.50 % to 2.00 % based on the Company’s total leverage ratio.
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Senior Unsecured Notes
In March 2025, the Company issued $450 million aggregate principal amount of 6.5 % senior unsecured notes due April 2033, which have an effective interest rate of 6.84 %. The net proceeds of $440.7 million were used to repurchase a portion of the Convertible Notes. The senior unsecured notes contain leverage and fixed charge coverage ratio covenants, both of which are measured upon the incurrence of future debt, as well as other customary covenants.
Carrying Value
At the end of each period, the carrying value of the Company’s debt was comprised of the following:
(in millions) | September 30, 2025 | December 31, 2024 | |||||||||
Convertible Senior Notes | $ | $ | |||||||||
Term Loan B | |||||||||||
Senior Unsecured Notes | |||||||||||
| Equipment financings | |||||||||||
| Mortgage | |||||||||||
| Total debt, net | $ | $ | |||||||||
Note 10. Financial Instruments and Fair Value
Fair value disclosures for equity investments without readily determinable fair values are disclosed in note 7.
Financial Instruments Disclosed at Fair Value
The following tables provide a summary of the significant financial instruments that are disclosed at fair value on a recurring basis:
| Fair Value Measurements at September 30, 2025 | |||||||||||||||||||||||
| (in millions) | Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||
Term Loan B(1) | $ | $ | $ | $ | |||||||||||||||||||
Senior Unsecured Notes(1) | |||||||||||||||||||||||
Equipment financings(2) | |||||||||||||||||||||||
Mortgage(2) | |||||||||||||||||||||||
| Total | $ | $ | $ | $ | |||||||||||||||||||
| Fair Value Measurements at December 31, 2024 | |||||||||||||||||||||||
| (in millions) | Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||
Term Loan B(1) | $ | $ | $ | $ | |||||||||||||||||||
Convertible Senior Notes(1) | |||||||||||||||||||||||
Equipment financings(2) | |||||||||||||||||||||||
Mortgage(2) | |||||||||||||||||||||||
| Total | $ | $ | $ | $ | |||||||||||||||||||
(1) Fair value was determined using quoted market prices obtained from third-party pricing sources.
(2) Fair value approximates carrying value and was determined using the cost basis.
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Financial Instruments Measured at Fair Value on a Recurring Basis
The following tables provide a summary of financial instruments that are measured at fair value on a recurring basis:
| Fair Value Measurements at September 30, 2025 | |||||||||||||||||||||||
| (in millions) | Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||
Assets: | |||||||||||||||||||||||
Cash(1) | $ | $ | $ | $ | |||||||||||||||||||
Money market mutual funds(1) | |||||||||||||||||||||||
Term deposits(1) | |||||||||||||||||||||||
Interest rate swaps(2) | |||||||||||||||||||||||
Total assets at fair value | $ | $ | $ | $ | |||||||||||||||||||
Liabilities: | |||||||||||||||||||||||
Interest rate swaps(2) | $ | $ | $ | $ | |||||||||||||||||||
| Fair Value Measurements at December 31, 2024 | |||||||||||||||||||||||
| (in millions) | Level 1 | Level 2 | Level 3 | Total | |||||||||||||||||||
Cash(1) | $ | $ | $ | $ | |||||||||||||||||||
Money market mutual funds(1) | |||||||||||||||||||||||
Interest rate swaps(2) | |||||||||||||||||||||||
Debt securities(3) | |||||||||||||||||||||||
Total assets at fair value | $ | $ | $ | $ | |||||||||||||||||||
(1) Cash and cash equivalents are carried at face amounts, which approximate their fair values.
(2) Fair value represents the estimated amounts the Company would receive or pay to terminate the contracts and is determined using industry standard valuation models and market-based observable inputs, including credit risk and interest rate yield curves. The fair value of the swaps is included in other assets at September 30, 2025 and in prepaid expenses and other current assets at December 31, 2024.
(3) Fair value is determined using a discounted cash flow valuation model and market-based unobservable inputs, including credit spread and risk free rate ranging from 4.0 % to 4.7 %.
Judgment is involved in estimating inputs, such as discount rates, used in Level 3 fair value measurements. Changes to these inputs can have a significant effect on fair value measurements and amounts that could be realized. There were no changes in the fair value of the Level 3 debt securities during the three and nine months ended September 30, 2024, nor during the three months ended September 30, 2025. Below is a reconciliation of changes in fair value of our debt securities for the nine months ended September 30, 2025.
| (in millions) | Debt Securities | ||||
| Balance at beginning of period | $ | ||||
Provision for credit loss included in selling, general and administrative expenses | ( | ||||
| Balance at the end of period | $ | ||||
Below is a reconciliation of changes in fair value of other investments for the three and nine months ended September 30, 2024.
| (in millions) | Three Months Ended September 30, 2024 | Nine Months Ended September 30, 2024 | |||||||||
Balance at beginning of period | $ | $ | |||||||||
Unrealized loss included in other expense, net | ( | ( | |||||||||
Balance at the end of period | $ | $ | |||||||||
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Note 11. Derivative Instruments
The Company manages interest rate exposure through the use of interest rate swap transactions with financial institutions acting as principal counterparties. In April 2025, the Company’s previous interest rate swaps expired and were replaced with interest rate swaps in which the Company receives variable rate interest payments and pays fixed interest at a weighted average rate of 3.47 % on a total notional value of $460.0 million of the Term Loan B. The interest rate swaps have been designated as cash flow hedges.
As of September 30, 2025, the amount of net gains related to the interest rate swaps included in accumulated other comprehensive income will be reclassified into the statement of income over the next 12 months was insignificant. When recognized, gains and losses on cash flow hedges reclassified from accumulated other comprehensive income (loss) are recognized within interest expense in the consolidated statement of income.
As discussed in Note 9, in June 2025, the Company provided notice of redemption for the remaining $380.1 million aggregate principal amount of its outstanding Convertible Notes. The Convertible Notes were fully redeemed in August 2025 for cash based on the Company's volume-weighted average stock price over the redemption period. The election to redeem the notes in cash resulted in an embedded derivative, which required bifurcation from the host debt instrument. The embedded derivative represented the variability in the cash settlement over the redemption period and subsequent changes in fair value based on the change in stock price over the redemption period were recognized in earnings. As a result, the Company recognized a gain of $12.5 12.5
Note 12. Commitments and Contingencies
Legal Proceedings
On April 24, 2025, the United States District Court for the District of Massachusetts entered final judgment in favor of Insulet Corporation in its ongoing litigation against EOFlow Co., Ltd.; EOFlow, Inc.; Nephria Bio, Inc.; and EOFlow’s CEO, Jesse Kim (collectively, “Defendants”), Insulet Corp. v. EOFlow Co. Ltd. et al., 1:23-cv-11780-FDS (D. Mass.). The litigation concerned the Defendants’ misappropriation of Insulet’s proprietary trade secrets relating to the design and manufacture of the Omnipod insulin patch pump. On December 3, 2024, a unanimous jury found four trade secrets asserted by Insulet valid and misappropriated and awarded Insulet total damages of $452 million, composed of $170 million in compensatory damages and $282 million in exemplary damages. The Court’s April 24, 2025 orders upheld the jury verdict and further entered a permanent injunction against Defendants. The injunction prohibits Defendants and others subject to the order from using, possessing, selling, distributing, or seeking regulatory approval for any products that were designed, developed, or manufactured, in whole or in part, using or relying on Insulet’s trade secrets. The injunction is worldwide and took effect immediately subject to a limited exception that permits six months of continuing sales to those patients of EOFlow that existed in the Republic of Korea and the European Union as of October 2023. The permanent injunction further requires EOFlow to assign certain patent applications to Insulet, disgorge any break-up fees received from Medtronic in connection with a previously contemplated acquisition, and submit to ongoing audits to ensure compliance with the Court’s orders. In view of the scope of the permanent injunction, the Court reduced Insulet’s monetary award to $59.4 million to avoid a double recovery.
Note 13. Segment and Geographic Data
The Company’s product offering primarily consists of the Omnipod platform and drug delivery device based on the Omnipod platform. Operating segments are defined as components of an enterprise for which separate financial information is available that is evaluated on a regular basis by the chief operating decision-maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance of the segment. The Company has concluded that its Chief Executive Officer (“CEO”) is the CODM as the CEO is the ultimate decision maker for key operating decisions, determining the allocation of resources and assessing the financial performance of the Company. The Company operates under one
16
Geographic information about revenue, based on customer location, is as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| (in millions) | 2025 | 2024 | 2025 | 2024 | |||||||||||||||||||
| U.S. | $ | $ | $ | $ | |||||||||||||||||||
| International | |||||||||||||||||||||||
| Total revenue | $ | $ | $ | $ | |||||||||||||||||||
There were no significant segment expenses that are regularly provided to the CODM other than those reported in the Company’s condensed consolidated statements of income for the three and nine months ended September 30, 2025 and 2024.
Geographic information about long-lived assets, net, excluding goodwill and other intangible assets is as follows:
| (in millions) | September 30, 2025 | December 31, 2024 | |||||||||
| U.S. | $ | $ | |||||||||
| Malaysia | |||||||||||
| China | |||||||||||
| Other | |||||||||||
| Total long-lived assets, net | $ | $ | |||||||||
Note 14. Equity
Equity Award Plan
In May 2025, the Company adopted the 2025 Stock Option and Incentive Plan (the “2025 Plan”), which replaced its previous stock option and incentive plan. The 2025 Plan provides for a maximum of 7.4 million shares to be issued.
Stock-Based Compensation Expense
Compensation expense related to stock-based awards was recorded as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| (in millions) | 2025 | 2024 | 2025 | 2024 | |||||||||||||||||||
| Cost of revenue | $ | $ | $ | $ | |||||||||||||||||||
| Research and development expenses | |||||||||||||||||||||||
| Selling, general and administrative expenses | |||||||||||||||||||||||
| Total | $ | $ | $ | $ | |||||||||||||||||||
Performance Share Units
During the nine months ended September 30, 2025, the Company granted 119,459 performance stock units (“PSUs”) with a weighted-average grant-date fair value per share of $299.58 . The PSUs included a relative total shareholder return (total shareholder return for the Company compared with total shareholder return of a peer group) as a market component. Depending on the achievement of the performance criteria and the Company’s relative market performance during the three-year performance period, a recipient of the award could ultimately vest at up to 250 % of the target award. Stock-based payments that contain both performance and market condition are recognized when performance conditions are probable of being achieved based on the grant date fair value. The Company uses the Monte Carlo model to estimate the probability of satisfying the market condition. The weighted-average assumptions used in the Monte Carlo model for PSUs granted were:
Risk-free interest rate | |||||
| Expected stock price volatility | |||||
| Peer group stock price volatility | |||||
| Correlation of returns | |||||
Deferred Compensation Plan
The Company has an unfunded, non-qualified deferred compensation plan for non-employee directors that allows participants to defer receipt of RSUs or cash compensation in the form of stock until a later date. Deferred awards are credited to a deferred stock account. The shares are held in a rabbi trust, which is classified and accounted for as equity in a manner consistent with the accounting for treasury stock. As of September 30, 2025, 3,495 shares were held in the trust. No shares were held in the trust as of December 31, 2024. The shares will be distributed when board service ceases.
17
Share Repurchase Program
In March 2025, the Company’s Board of Directors authorized a program to repurchase up to $125 million of common stock through December 31, 2026 to offset dilution from stock-based compensation. During the three and nine months ended September 30, 2025, the Company repurchased approximately 91 thousand shares for $29.6 million and 184 thousand shares for $59.6 million, respectively.
Note 15. Income Taxes
The Company’s effective tax rate was 28.7 % and 27.0 % for the three and nine months ended September 30, 2025, respectively. For both the three and nine months ended September 30, 2025, the tax rate varied from the U.S. statutory rate primarily due to non-deductible charges from the repurchase of the Company’s convertible debt.
Note 16. Earnings Per Share
Basic earnings per share is computed by dividing net income by the weighted average number of common shares outstanding for the period. Diluted earnings per share is computed using the weighted average number of common shares outstanding and, when dilutive, common share equivalents. The computation of basic and diluted earnings per share was as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
(in millions, except share and per share data) | 2025 | 2024 | 2025 | 2024 | |||||||||||||||||||
Net income | $ | $ | $ | $ | |||||||||||||||||||
Add back interest expense, net of tax | |||||||||||||||||||||||
Net income, diluted | $ | $ | $ | $ | |||||||||||||||||||
| Weighted average number of common shares outstanding, basic (in thousands) | |||||||||||||||||||||||
Restricted stock units | |||||||||||||||||||||||
Stock options | |||||||||||||||||||||||
Convertible Senior Notes | |||||||||||||||||||||||
Weighted average number of common shares outstanding, diluted (in thousands) | |||||||||||||||||||||||
Earnings per share: | |||||||||||||||||||||||
Basic | $ | $ | $ | $ | |||||||||||||||||||
Diluted | $ | $ | $ | $ | |||||||||||||||||||
The number of common share equivalents excluded from the computation of diluted earnings per share because either the effect would have been anti-dilutive, or the performance criteria related to the units had not yet been met, were as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
(in thousands) | 2025 | 2024 | 2025 | 2024 | |||||||||||||||||||
Restricted stock units | |||||||||||||||||||||||
Stock options | |||||||||||||||||||||||
| Total | |||||||||||||||||||||||
18
Note 17. Accumulated Other Comprehensive Income
Changes in the components of accumulated other comprehensive income (loss), net of tax, were as follows:
| Three Months Ended September 30, 2025 | Nine Months Ended September 30, 2025 | ||||||||||||||||||||||||||||||||||||||||||||||
| (in millions) | Foreign Currency Translation Adjustment | Unrealized Loss on Securities | Unrealized Gain on Cash Flow Hedges | Accumulated Other Comprehensive Income | Foreign Currency Translation Adjustment | Unrealized Loss on Securities | Unrealized Gain on Cash Flow Hedges | Accumulated Other Comprehensive (Loss) Income | |||||||||||||||||||||||||||||||||||||||
| Balance at beginning of period | $ | $ | ( | $ | $ | $ | ( | $ | ( | $ | $ | ( | |||||||||||||||||||||||||||||||||||
Other comprehensive income (loss) before reclassifications | ( | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||||||
Amounts reclassified to net income (1) | |||||||||||||||||||||||||||||||||||||||||||||||
| Balance at the end of period | $ | $ | ( | $ | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||||||||||
| Three Months Ended September 30, 2024 | Nine Months Ended September 30, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||
| (in millions) | Foreign Currency Translation Adjustment | Unrealized Loss on Securities | Unrealized Gain on Cash Flow Hedges | Accumulated Other Comprehensive (Loss) Income | Foreign Currency Translation Adjustment | Unrealized Loss on Securities | Unrealized Gain on Cash Flow Hedges | Accumulated Other Comprehensive Income | |||||||||||||||||||||||||||||||||||||||
| Balance at beginning of period | $ | ( | $ | ( | $ | $ | ( | $ | ( | $ | ( | $ | $ | ||||||||||||||||||||||||||||||||||
Other comprehensive loss before reclassifications | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
Amounts reclassified to net income (1) | |||||||||||||||||||||||||||||||||||||||||||||||
| Balance at the end of period | $ | $ | ( | $ | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||||||||||
(1) Presented net of income taxes, the amounts of which are insignificant. There is no
Note 18. Subsequent Event
In October 2025, the Company repaid the remaining $59.1 million outstanding under its mortgage upon maturity.
19
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 accompanying notes included in this quarterly report. The following discussion may contain forward-looking statements that reflect our plans, estimates and beliefs, which are subject to risks, uncertainties and assumptions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to these differences include those discussed under the headings “Risk Factors” and “Forward-Looking Statements” in both our Annual Report on Form 10-K for the year ended December 31, 2024 and in this quarterly report. Columns and rows within tables may not add due to rounding. Percentages have been calculated using actual, non-rounded figures.
Overview
Our mission is to improve the lives of people with diabetes. We are primarily engaged in the development, manufacture, and sale of our proprietary Omnipod product platform, a continuous insulin delivery system for people with insulin-dependent diabetes. The Omnipod platform primarily includes our most recent generation Omnipod 5 and its predecessor Omnipod DASH, which eliminate the need for multiple daily injections using syringes or insulin pens or the use of pump and tubing. Omnipod 5, which builds on our Omnipod DASH mobile platform, is a tubeless automated insulin delivery system that integrates with continuous glucose monitors (“CGM”) to manage blood sugar and is fully controlled by a compatible personal smartphone or Omnipod 5 Controller. It is indicated for type 1 diabetes and, in the United States, for type 2 diabetes for ages 18 and up. The CGM is sold separately by third parties. Omnipod DASH features a secure Bluetooth enabled Pod that is controlled by a smartphone-like Personal Diabetes Manager (“PDM”) with a color touch screen user interface.
Our financial objective is to sustain profitable growth. To achieve this, we announced the launch of Omnipod 5 in the following nine additional countries this year: Italy, Denmark, Finland, Norway, Sweden, Australia, Belgium, Canada and Switzerland. Additionally, we are working on further building our international teams and advancing our regulatory, reimbursement, and market development efforts so we can bring Omnipod 5 to additional international markets.
We have completed the randomized portion of our RADIANT study in France, the United Kingdom, and Belgium, which is our Omnipod 5 with Libre 2 randomized controlled trial. Similar to the randomized control trial that we completed in the United States and France for Omnipod 5 with DexCom’s G6 CGM sensor, the objective is to provide data to support our pricing and market access initiatives as we roll out Omnipod 5 with multiple sensors across our international markets. We also continue to expand market access and awareness of Omnipod products through our direct to consumer advertising programs and through growing our presence in the U.S. pharmacy channel, where access to Omnipod 5 and Omnipod DASH is simpler and affordable, as no up-front investment is required.
Additionally, we continue to focus on our product development efforts, including automated insulin delivery (“AID”) offerings, such as choice of smartphone integration and CGM, and enhancing the customer experience through digital product and data capabilities. In 2025, our Omnipod 5 app for iPhone compatible with Dexcom’s G7 CGM sensor became fully available in the United States. Further, we integrated Omnipod 5 with Dexcom’s G7 CGM sensor in Germany, Sweden, Denmark, Finland and Italy, and with Abbott’s FreeStyle Libre 2 Plus sensor in Australia.
Results of Operations
Factors Affecting Operating Results
Our Pod is intended to be used continuously for up to three days, after which it may be replaced with a new disposable Pod. The unique patented design of the Omnipod allows us to provide Pod therapy at a relatively low or no up-front investment in regions where reimbursement allows for it and our pay-as-you-go pricing model reduces the risk to third-party payors. As we grow our customer base, we expect to generate an increasing portion of our revenues through recurring sales of our disposable Pods, which provide recurring revenue.
20
Revenue
| Three Months Ended September 30, | |||||||||||||||||||||||||||||
| (dollars in millions) | 2025 | 2024 | Percent Change | Currency Impact | Constant Currency(1) | ||||||||||||||||||||||||
| U.S. | $ | 497.1 | $ | 395.6 | 25.6 | % | — | % | 25.6 | % | |||||||||||||||||||
| International | 202.1 | 137.9 | 46.5 | % | 6.6 | % | 39.9 | % | |||||||||||||||||||||
| Total Omnipod Products | 699.2 | 533.5 | 31.0 | % | 1.7 | % | 29.3 | % | |||||||||||||||||||||
| Drug Delivery | 7.1 | 10.3 | (31.4) | % | — | % | (31.4) | % | |||||||||||||||||||||
| Total | $ | 706.3 | $ | 543.9 | 29.9 | % | 1.7 | % | 28.2 | % | |||||||||||||||||||
| Nine Months Ended September 30, | |||||||||||||||||||||||||||||
| (dollars in millions) | 2025 | 2024 | Percent Change | Currency Impact | Constant Currency(1) | ||||||||||||||||||||||||
| U.S. | $ | 1,352.0 | $ | 1,065.6 | 26.9 | % | — | % | 26.9 | % | |||||||||||||||||||
| International | 540.2 | 381.4 | 41.6 | % | 3.3 | % | 38.4 | % | |||||||||||||||||||||
| Total Omnipod Products | 1,892.2 | 1,447.0 | 30.8 | % | 0.9 | % | 29.9 | % | |||||||||||||||||||||
| Drug Delivery | 32.2 | 27.1 | 18.5 | % | — | % | 18.5 | % | |||||||||||||||||||||
| Total | $ | 1,924.3 | $ | 1,474.1 | 30.5 | % | 0.8 | % | 29.7 | % | |||||||||||||||||||
(1) Constant currency revenue growth is a non-GAAP financial measure, which should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. See “Management’s Use of Non-GAAP Measures.”
Total revenue for the three months ended September 30, 2025 increased $162.4 million, or 29.9%, to $706.3 million, compared with $543.9 million for the three months ended September 30, 2024. Total revenue for the nine months ended September 30, 2025 increased $450.2 million, or 30.5%, to $1,924.3 million, compared with $1,474.1 million for the nine months ended September 30, 2024. Constant currency revenue growth of 28.2% and 29.7% for the three and nine months ended September 30, 2025, respectively, was primarily driven by higher sales volume largely attributable to our growing customer base and, to a lesser extent, higher price.
U.S.
Revenue from the sale of Omnipod products in the U.S. increased $101.5 million, or 25.6%, to $497.1 million for the three months ended September 30, 2025, compared with $395.6 million for the three months ended September 30, 2024. This increase primarily resulted from higher sales volume driven by growing our customer base. A higher average selling price resulting from our wholesaler acquisition cost increase implemented during the second quarter of 2025 also contributed to the revenue increase, although to a lesser extent. Revenue from the sale of Omnipod products in the U.S. for the three months ended September 30, 2025 included $184.5 million of related party revenue, compared with $171.3 million for the three months ended September 30, 2024. The $13.3 million increase resulted from growth through the pharmacy channel.
Revenue from the sale of Omnipod products in the U.S. increased $286.3 million, or 26.9%, to $1,352.0 million for the nine months ended September 30, 2025, compared with $1,065.6 million for the nine months ended September 30, 2024. This increase primarily resulted from higher sales volume driven by growing our customer base. Revenue from the sale of Omnipod products in the U.S. for the nine months ended September 30, 2025 included $511.6 million of related party revenue, compared with $430.4 million for the nine months ended September 30, 2024. The $81.2 million increase resulted from growth through the pharmacy channel.
For full year 2025, we expect strong U.S. revenue growth primarily driven by the benefits of our recurring revenue model and continued volume growth of Omnipod 5.
International
Revenue from the sale of Omnipod products in our international markets increased $64.1 million, or 46.5%, to $202.1 million for the three months ended September 30, 2025, compared with $137.9 million for the three months ended September 30, 2024. Excluding the 6.6% favorable impact of currency exchange, the remaining 39.9% increase in revenue was primarily due to higher volumes from our growing customer base, largely resulting from the prior year launches of Omnipod 5. A higher average selling price for Omnipod 5, compared with Omnipod DASH, also contributed to the revenue increase.
Revenue from the sale of Omnipod products in our international markets increased $158.8 million, or 41.6%, to $540.2 million for the nine months ended September 30, 2025, compared with $381.4 million for the nine months ended September 30, 2024. Excluding the 3.3% favorable impact of currency exchange, the remaining 38.4% increase in revenue was primarily due to higher volumes from our growing customer base, largely resulting from the prior year launches of Omnipod 5. A higher average selling price for Omnipod 5, compared with Omnipod DASH, also contributed to the revenue increase.
For full year 2025, we expect higher International Omnipod revenue due to continued volume growth driven by new customers and higher price resulting from conversions to Omnipod 5 primarily due to the launch of Omnipod 5 in Australia, Canada and the Nordic countries, growth from the prior year launches, primarily France, and the continued roll out of Omnipod 5 in additional markets.
21
Drug Delivery
Substantially all of our Drug Delivery revenue consists of sales of pods to Amgen for use in the Neulasta® Onpro® kit, a delivery system for Amgen’s Neulasta to help reduce the risk of infection after intense chemotherapy. Drug Delivery revenue was $7.1 million and $10.3 million for the three months ended September 30, 2025 and 2024, respectively and $32.2 million and $27.1 million for the nine months ended September 30, 2025 and 2024, respectively.
Costs and Expenses
| Three Months Ended September 30, | |||||||||||||||||||||||
| 2025 | 2024 | ||||||||||||||||||||||
| (dollars in millions) | Amount | Percent of Revenue | Amount | Percent of Revenue | |||||||||||||||||||
| Cost of revenue | $ | 196.2 | 27.8 | % | $ | 166.8 | 30.7 | % | |||||||||||||||
| Research and development expenses | $ | 77.2 | 10.9 | % | $ | 54.9 | 10.1 | % | |||||||||||||||
| Selling, general and administrative expenses | $ | 315.2 | 44.6 | % | $ | 234.1 | 43.0 | % | |||||||||||||||
| Nine Months Ended September 30, | |||||||||||||||||||||||
| 2025 | 2024 | ||||||||||||||||||||||
| (dollars in millions) | Amount | Percent of Revenue | Amount | Percent of Revenue | |||||||||||||||||||
| Cost of revenue | $ | 553.0 | 28.7 | % | $ | 459.3 | 31.2 | % | |||||||||||||||
| Research and development expenses | $ | 210.2 | 10.9 | % | $ | 159.0 | 10.8 | % | |||||||||||||||
| Selling, general and administrative expenses | $ | 833.6 | 43.3 | % | $ | 656.3 | 44.5 | % | |||||||||||||||
Cost of Revenue
Cost of revenue for the three months ended September 30, 2025 increased $29.4 million, or 17.6%, to $196.2 million, compared with $166.8 million for the three months ended September 30, 2024. Gross margin was 72.2% for the three months ended September 30, 2025, compared with 69.3% for the three months ended September 30, 2024. The 290 basis point increase in gross margin was primarily driven by a higher average selling price and increased manufacturing scale and efficiencies.
Cost of revenue for the nine months ended September 30, 2025 increased $93.7 million, or 20.4%, to $553.0 million, compared with $459.3 million for the nine months ended September 30, 2024. Gross margin was 71.3% for the nine months ended September 30, 2025, compared with 68.8% for the nine months ended September 30, 2024. The 240 basis point increase in gross margin was primarily driven by improved manufacturing and supply chain efficiencies, a higher average selling price, increased volume and a $13.5 million charge in the prior year related to certain components utilized in OmnipodGO, which we decided not to commercialize.
For full year 2025, we expect gross margin to be over 71.0%. We anticipate gross margin to increase compared with 2024 primarily due to improved manufacturing efficiencies, pricing benefits and the charge in the prior year related to certain components utilized in OmnipodGO, which did not repeat. While we do not expect tariffs to have a significant impact on our gross margin in 2025, should the exemption that is currently in place for certain medical devices be eliminated, tariffs would have a material impact on our results of operations in future years.
Research and Development Expenses
Research and development expenses for the three months ended September 30, 2025 increased $22.3 million, or 40.6%, to $77.2 million, compared with $54.9 million for the three months ended September 30, 2024. Research and development expenses as a percent of revenue was 10.9% and 10.1% for the three months ended September 30, 2025 and 2024, respectively. Research and development expenses for the nine months ended September 30, 2025 increased $51.2 million, or 32.2%, to $210.2 million, compared with $159.0 million for the nine months ended September 30, 2024. Research and development expenses as a percentage of revenue was 10.9% and 10.8% for the nine months ended September 30, 2025 and 2024, respectively. The increases in research and development expense in both the three and nine months ended September 30, 2025 were primarily due to year-over-year headcount additions to support continued investment in our Omnipod and pipeline products and, to a lesser extent, higher consulting costs to support our Omnipod and next generation products and clinical trials.
We expect research and development spending in 2025 to increase compared with 2024 as we continue to invest in advancing our innovation and clinical pipeline.
22
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the three months ended September 30, 2025 increased $81.1 million, or 34.7%, to $315.2 million, compared with $234.1 million for the three months ended September 30, 2024. Selling, general and administrative expenses for the nine months ended September 30, 2025 increased $177.3 million, or 27.0%, to $833.6 million, compared with $656.3 million for the nine months ended September 30, 2024. The increases in selling, general and administrative expense for both the three and nine months ended September 30, 2025 were primarily attributable to year-over-year headcount additions to enhance customer product support and support both our business growth and Omnipod 5. Incremental advertising expense $20.7 million and $26.5 million for the three and nine months ended September 30, 2025, respectively, also contributed to the increases in selling, general and administrative expenses, although to a lesser extent.
We expect selling, general and administrative expenses to increase in 2025 compared with 2024 due to investments in our operating structure, primarily headcount additions, particularly in the areas of customer and Omnipod 5 support, sales, quality and regulatory support, and international expansion to facilitate continued growth globally. We also plan to make additional investments to expand awareness of Omnipod products through our direct to consumer advertising programs. Additionally, we continue to support the Omnipod platform and the phased launch of Omnipod 5 in our existing international markets and prepare for expansion into new countries.
Non-Operating Items
Interest Expense and Income
Interest expense increased $3.3 million to $15.6 million for the three months ended September 30, 2025, compared with $12.4 million for the three months ended September 30, 2024. Interest expense increased $10.4 million to $44.5 million for the nine months ended September 30, 2025, compared with $34.1 million for the nine months ended September 30, 2024. The increase in interest expense for both the three and nine months ended September 30, 2025 primarily resulted from the issuance of 6.5% senior unsecured notes in March 2025 and lower gains on the new interest rate swaps entered into in April 2025. These increases were partially offset by lower interest on our Term Loan B resulting from the refinancing in August 2024.
Interest income decreased $1.9 million to $8.6 million for the three months ended September 30, 2025, compared with $10.5 million for the three months ended September 30, 2024. The decrease in interest income was driven by higher average cash balances, partially offset by lower average interest rates. Interest income of $29.0 million for the nine months ended September 30, 2025 was level with interest income for the nine months ended September 30, 2024.
We expect net interest expense for the full year 2025 to increase approximately $20 million compared with 2024 due to the debt transactions discussed in note 9 and the replacement of our interest rate swaps that expired in April 2025 discussed in note 11.
Other income (expense), net
Other income, net was $12.1 million and $11.2 million for the three and nine months ended September 30, 2025, respectively. Both periods include a gain of $12.5 million resulting from the change in fair value of the derivative asset associated with the redemption of our convertible debt discussed in note 11.
Other expense, net was $3.4 million and $5.9 million for the three and nine months ended September 30, 2024, respectively. These amounts were driven by a $2.1 million and $3.8 million loss during the three and nine months ended September 30, 2024, respectively, resulting from fair value adjustments for a strategic debt investment.
Income Tax (Expense) Benefit
Our effective tax rate was 28.7% and 27.0% for the three and nine months ended September 30, 2025, respectively, compared with an effective tax rate of 6.5% and a tax benefit of 68.2% for the three and nine months ended September 30, 2024, respectively. The increases in the effective tax rates for both periods were primarily due to the absence of a valuation allowance against deferred tax assets that existed in the prior year and the loss on extinguishment of debt during the nine months ended September 30, 2025.
The Organization for Economic Co-operation and Development (“OECD”) and participating countries continue to work toward the enactment of a 15% global minimum corporate tax. More than 50 countries, including the Netherlands and the United Kingdom (among others) in which we operate, have thus far enacted elements of the global minimum tax legislation which continue to be effective for us throughout fiscal 2025. The global minimum tax is a significant structural change to the international taxation framework. We anticipate further legislative activity and administrative guidance throughout 2025. Overall, the legislation as currently enacted did not impact our consolidated financial statements for the nine months ended September 30, 2025. We are continuing to evaluate the potential impact on future periods.
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In July 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the United States. The OBBBA includes the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions, including immediate expensing for domestic research expenditures. Additionally, the OBBBA allows accelerated tax deductions for qualified property. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. During the three and nine months ended September 30, 2025, we recorded a net tax benefit resulting from the provisions of the OBBBA, the amount of which was not significant; however, optional tax elections are available, which we are continuing to assess, that could affect the ultimate impact of the OBBBA on our consolidated financial statements for the year ending December 31, 2025.
Adjusted EBITDA
The table below presents reconciliations of Adjusted EBITDA, a non-GAAP financial measure, to net income, the most directly comparable financial measure prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| (in millions) | 2025 | 2024 | 2025 | 2024 | |||||||||||||||||||
| Net income | $ | 87.6 | $ | 77.5 | $ | 145.5 | $ | 317.6 | |||||||||||||||
Interest expense, net | 7.0 | 1.8 | 15.5 | 4.8 | |||||||||||||||||||
Income tax expense (benefit) | 35.2 | 5.4 | 53.9 | (128.8) | |||||||||||||||||||
| Depreciation and amortization | 22.0 | 21.3 | 66.0 | 59.3 | |||||||||||||||||||
Stock-based compensation(1) | 16.7 | 18.2 | 42.4 | 49.3 | |||||||||||||||||||
CEO and CFO transition(2) | 4.0 | — | 9.4 | — | |||||||||||||||||||
Loss on extinguishment of debt(3) | — | — | 123.9 | — | |||||||||||||||||||
Gain on derivative asset(4) | (12.5) | — | (12.5) | — | |||||||||||||||||||
Loss on investments(5) | — | 2.1 | 7.5 | 3.8 | |||||||||||||||||||
| Adjusted EBITDA | $ | 160.0 | $ | 126.2 | $ | 451.5 | $ | 306.1 | |||||||||||||||
(1) Includes the reversal of stock-based compensation expense associated with the departure of the Company's former Chief Executive Officer and Chief Financial Officer totaling $1.0 million and $11.7 million for the three and nine months ended September 30, 2025, respectively.
(2) Represents severance benefits for the Company's former Chief Executive Officer and Chief Financial Officer.
(3) Relates to the repurchase of a portion of our convertible debt.
(4) Represents the change in fair value of the derivative asset associated with the redemption of our convertible debt.
(5) Represents losses associated with debt and equity investments.
Non-GAAP Financial Measures
Management uses the non-GAAP financial measures described below.
Constant currency revenue growth represents the change in revenue between current and prior year periods using the exchange rate in effect during the applicable prior year period. We present constant currency revenue growth because we believe it provides meaningful information regarding our results on a consistent and comparable basis. Management uses this non-GAAP financial measure, in addition to financial measures in accordance with GAAP, to evaluate our operating results. It is also one of the performance metrics that determines management incentive compensation.
Adjusted EBITDA represents net income plus net interest expense (income), income tax expense (benefit), depreciation and amortization, stock-based compensation expense and other significant transactions or events, such as legal settlements, medical device corrections, gains (losses) on investments, and loss on extinguishment of debt, which affect the period-to-period comparability of our performances, as applicable. We present Adjusted EBITDA because management uses it as a supplemental measure in assessing our performance, and we believe that it is helpful to investors and other interested parties as a measure of our comparative performance from period to period. Adjusted EBITDA is a commonly used measure in determining business value and we use it internally to report results.
Free cash flow, a non-GAAP measure, is calculated as net cash provided by operating activities less capital expenditures. Management uses this non-GAAP measure, in addition to U.S. GAAP financial measures, to evaluate our operating results.
These non-GAAP financial measures should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. In addition, the above definitions may differ from similarly titled measures used by others. Non-GAAP financial measures exclude the effect of items that increase or decrease our reported results of operations; accordingly, we strongly encourage investors to review our consolidated financial statements in their entirety.
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Liquidity and Capital Resources
Contractual Obligations
In 2025, we entered into a purchase agreement with NXP USA, Inc. pursuant to which we are committed to purchasing semi-conductor chips for approximately $30 million as of September 30, 2025. See note 9 for information on the debt transactions that were executed during the nine months ended September 30, 2025.
We believe that our current liquidity as further described below will be sufficient to meet our projected operating, investing and debt service requirements for at least the next twelve months.
Capitalization
The following table contains several key measures to gauge our financial condition and liquidity at the end of each period:
(dollars in millions) | September 30, 2025 | December 31, 2024 | ||||||||||||
| Cash and cash equivalents | $ | 757.4 | $ | 953.4 | ||||||||||
| Current portion of long-term debt | $ | 79.9 | $ | 83.8 | ||||||||||
| Long-term debt, net | $ | 934.9 | $ | 1,296.1 | ||||||||||
| Total debt, net | $ | 1,014.8 | $ | 1,379.8 | ||||||||||
| Total stockholders’ equity | $ | 1,384.1 | $ | 1,211.6 | ||||||||||
| Debt-to-total capital ratio | 42 | % | 53 | % | ||||||||||
| Net debt-to-total capital ratio | 11 | % | 16 | % | ||||||||||
Credit Agreement
We have a $500 million senior secured revolving credit facility (the “Revolving Credit Facility”), which expires in 2030. At September 30, 2025, no amount was outstanding under the Revolving Credit Facility. The Revolving Credit Facility contains a covenant to maintain a specified leverage ratio when there are amounts of at least 35% of the aggregate Revolving Credit Facility outstanding. It also contains other customary covenants, none of which are considered restrictive to our operations. Additionally, we have a Term Loan B, which matures in 2031, that contains covenants restricting or limiting our ability to incur additional indebtedness, make asset dispositions, create or permit liens, sell, transfer or exchange assets, guarantee certain indebtedness, and make acquisitions and other investments.
Senior Unsecured Notes
In March 2025, we issued $450 million aggregate principal amount of 6.5% senior unsecured notes due April 2033. The notes contain leverage and fixed charge coverage ratio covenants, both of which are measured upon the incurrence of future debt, as well as other customary covenants, none of which we consider restrictive to our operations. Additional information regarding our debt is provided in note 9 to the consolidated financial statements.
Mortgage
In October 2025, the Company repaid the remaining $59.1 million outstanding under its mortgage upon maturity.
Share Repurchase Program
In March 2025, the Company’s Board of Directors authorized a program to repurchase up to $125 million of common stock through December 31, 2026 to offset dilution from stock-based compensation. During the nine months ended September 30, 2025, we repurchased approximately 184 thousand shares for $59.6 million under this program.
Summary of Cash Flows
| Nine Months Ended September 30, | |||||||||||
| (in millions) | 2025 | 2024 | |||||||||
| Cash provided by (used in): | |||||||||||
| Operating activities | $ | 386.0 | $ | 282.7 | |||||||
| Investing activities | (69.9) | (78.2) | |||||||||
| Financing activities | (522.8) | (7.2) | |||||||||
| Effect of exchange rate changes on cash and cash equivalents | 10.8 | 1.3 | |||||||||
Net (decrease) increase in cash and cash equivalents | $ | (195.9) | $ | 198.5 | |||||||
25
Operating Activities
Net cash provided by operating activities of $386.0 million for the nine months ended September 30, 2025 was primarily attributable to net income, as adjusted for loss on extinguishment of debt, depreciation and amortization, stock-based compensation expense, and deferred income taxes, partially offset by a $37.6 million working capital outflow. The working capital outflow was driven by an $86.1 million increase in accounts receivable and a $55.5 million increase in prepaid expenses and other assets, partially offset by an $83.1 million increase in accrued expenses and other liabilities and a $25.6 million increase in accounts payable. The increase in accounts receivable was primarily due to an increase in sales driven by our growing customer base. The increase in prepaid expenses and other assets was primarily driven by prepaid income taxes and raw materials as well as cloud computing costs. The increase in accrued expenses and other liabilities was primarily driven by an increase in accrued rebates due to higher sales volume, an increase in accrued compensation driven by headcount additions to support our growing business and an increase in accrued interest resulting from the issuance of the 6.5% senior unsecured notes discussed in Note 9. Finally, the increase in accounts payable was driven by the timing of payments.
Investing Activities
Net cash used in investing activities was $69.9 million for the nine months ended September 30, 2025, compared with $78.2 million for the nine months ended September 30, 2024.
Capital Spending—Capital expenditures were $56.5 million for the nine months ended September 30, 2025, compared with $71.3 million for the nine months ended September 30, 2024. The $14.9 million decrease primarily related to the purchase of machinery, equipment and tooling during nine months ended September 30, 2024 for our Malaysia manufacturing facility which began operating mid-2024. We expect capital expenditures for 2025 to increase compared with 2024 as we continue to expand globally and optimize our manufacturing and supply chain operations. We expect to fund our capital expenditures using existing cash.
Investments in Developed Software—Investments in developed software were $13.5 million and $6.7 million for the nine months ended September 30, 2025 and 2024, respectively, and primarily related to investments in projects to support our cloud-based capabilities.
Financing Activities
Net cash used in financing activities was $522.8 million for the nine months ended September 30, 2025, compared with $7.2 million for the nine months ended September 30, 2024.
Debt Issuance and Repayments—During the nine months ended September 30, 2025, we received net proceeds of $440.7 million from the issuance of Senior Unsecured Notes and used the proceeds along with proceeds of $164.6 million from the unwinding the related capped call options to partially fund the $1,052.2 million repurchase of a portion of our Convertible Notes. During the nine months ended September 30, 2025, we also received proceeds of $15.5 million from the refinancing of Term Loan B, and we repaid $33.4 million of our Term Loan B, equipment financings, and mortgage, compared with $21.1 million during the nine months ended September 30, 2024. Additionally, during the nine months ended September 30, 2024, we refinanced our Term Loan B, which resulted in cash proceeds of $130.0 million, net of issuance costs, and the simultaneous repayment of $132.2 million of the Term Loan B.
Proceeds and Repayments from Secured Borrowing—During the nine months ended September 30, 2025 and 2024, we received cash advances net of repayments of $2.6 million and $15.4 million, respectively, from a third-party to whom we outsource our insurance claim submissions process in a certain country.
Finance Lease Repayments—During the nine months ended September 30, 2024, we made finance lease repayments associated with our Malaysia manufacturing facility totaling $6.0 million.
Proceeds from Option Exercises—Proceeds from option exercises were $17.2 million and $7.7 million for the nine months ended September 30, 2025 and 2024, respectively. The $9.5 million increase was primarily driven by a higher average option exercise price resulting from an increase in our stock price.
Payment of Taxes for Restricted Stock Net Settlements—Payments for taxes related to net restricted and performance stock unit settlements were $25.1 million and $7.0 million for the nine months ended September 30, 2025 and 2024, respectively. The $18.1 million increase was primarily driven by more RSU vestings during the current period due to headcount additions to support the growth of the business and a higher fair market value of the restricted stock units that vested during the period.
Repurchase of Common Stock—During the nine months ended September 30, 2025, we paid $59.6 million to repurchase common shares to offset dilution from stock-based compensation.
26
Free Cash Flow
Free cash flow was $329.5 million for the nine months ended September 30, 2025, compared with $211.3 million for the nine months ended September 30, 2024. The $118.2 million increase in free cash flow primarily resulted from an increase in operating income as adjusted for depreciation, amortization, and stock-based compensation expense.
Free cash flow is a non-GAAP measure, which should be considered supplemental to and not a substitute for our reported financial results prepared in accordance with U.S. GAAP. See “Non-GAAP Financial Measures” A reconciliation between net cash provided by operating activities (the most comparable U.S. GAAP measure) and free cash flow is as follows:
| Nine Months Ended September 30, | |||||||||||
| (in millions) | 2025 | 2024 | |||||||||
Net cash provided by operating activities | $ | 386.0 | $ | 282.7 | |||||||
Capital expenditures | (56.5) | (71.3) | |||||||||
| Free cash flow | $ | 329.5 | $ | 211.3 | |||||||
Critical Accounting Policies and Estimates
The preparation of our consolidated financial statements in conformity with GAAP requires management to use judgment in making estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities.
Our accounting policies for pharmacy rebates and income taxes are based on, among other things, judgments and assumptions made by management that include inherent risks and uncertainties. There have been no significant changes to the above critical accounting policies or in the underlying accounting assumptions and estimates used in such policies from those disclosed in our annual consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2024.
Accounting Standards Issued and Not Yet Adopted
In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires incremental annual income tax disclosures. The new guidance standardizes categories for the effective tax rate reconciliation and requires disaggregation of income taxes and additional income tax-related disclosures. We intend to adopt these new disclosure requirements prospectively beginning with our annual filing for 2025.
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40). The new guidance requires disaggregated disclosure of expenses included in certain expense captions presented in the statements of income as well as additional disclosures about selling expenses. We intend to adopt these new disclosure requirements beginning with our annual filing for 2027, as required. The guidance may be applied prospectively or retrospectively.
In July 2025, the FASB issued ASU 2025-05, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets. The new guidance provides a practical expedient to simplify the measurement of credit losses for certain receivables and contract assets. The guidance is effective for us beginning in the first quarter of 2026. Early adoption is permitted. Once adopted, the guidance is applied prospectively. We are currently evaluating the impact of this guidance.
In September 2025, the FASB issued ASU 2025-06, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software, which modernizes the internal-use software guidance by eliminating references to prescriptive and sequential software development stages. The guidance is effective for us beginning in the first quarter of 2027. Early adoption is permitted. The guidance may be applied prospectively, modified prospectively or retrospectively. We are currently evaluating the impact of this guidance.
FORWARD-LOOKING STATEMENTS
This quarterly report on Form 10-Q contains forward-looking statements. Forward-looking statements relate to future events or our future financial performance. We generally identify forward looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar words. These statements are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, results of operations and financial condition.
27
The outcomes of the events described in these forward-looking statements are subject to risks, uncertainties and assumptions. These risks and uncertainties include, but are not limited to:
•international regulatory, commercial and logistics business risks, including the implementation of tariffs;
•our dependence on a principal product platform;
•the impact of competitive products, technological change and product innovation;
•our ability to maintain an effective sales force and expand our distribution network;
•our ability to maintain and grow our customer base;
•our ability to scale the business to support revenue growth;
•our ability to secure and retain adequate coverage or reimbursement from third-party payors;
•the impact of healthcare reform laws;
•our ability to design, develop, manufacture and commercialize future products;
•unfavorable results of clinical studies, including issues with third parties conducting any studies, or future publication of articles or announcement of positions by diabetes associations or other organizations that are unfavorable;
•our ability to protect intellectual property and other proprietary rights;
•potential conflicts with the intellectual property of third parties;
•our inability to maintain or enter into new license or other agreements with respect to continuous glucose monitors, data management systems or other rights necessary to sell our current product and/or commercialize future products;
•worldwide macroeconomic and geopolitical uncertainty as well as risks associated with public health crises and pandemics, including government actions and restrictive measures implemented in response, supply chain disruptions, delays in clinical trials, and other impacts to the business, our customers, suppliers, and employees;
•the potential violation of anti-bribery/anti-corruption laws;
•the concentration of manufacturing operations and storage of inventory in a limited number of locations;
•supply problems or price fluctuations with sole source or third-party suppliers on which we are dependent;
•failure to retain key suppliers;
•challenges to the future development of our non-insulin drug delivery product line;
•our failure or that of our contract manufacturer or component suppliers to comply with the U.S. Food and Drug Administration’s quality system regulations or other manufacturing difficulties;
•extensive government regulation applicable to medical devices, as well as complex and evolving privacy and data protection laws;
•adverse regulatory or legal actions relating to current or future Omnipod products;
•potential adverse impacts resulting from a recall, or discovery of serious safety issues, or product liability lawsuits relating to off-label use;
•breaches or failures of our product or information technology systems, including by cyberattack;
•our ability to attract, motivate, and retain key personnel;
•risks associated with potential future acquisitions or investments in new businesses;
•ability to raise additional funds on acceptable terms or at all; and
•changes in tax laws or exposure to significant tax liabilities.
The risk factors discussed in “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and in this Quarterly Report could cause our results to differ materially from those expressed in forward-looking statements. In addition, there may be other risks and uncertainties that we are unable to predict at this time or that we currently do not expect to have a material adverse effect on our business. Actual results could differ materially from those projected in the forward-looking statements; accordingly, you should not rely upon forward-looking statements as predictions of future events. We expressly disclaim any obligation to update these forward-looking statements other than as required by law.
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Item 3. Quantitative and Qualitative Disclosures about Market Risk
Refer to “Part II. Item 7A. Quantitative and Qualitative Disclosures About Market Risk” in our Annual Report on Form 10-K for the year ended December 31, 2024 for a discussion of our foreign currency exchange risk.
Interest Rate Risk
Our exposure to changes in interest rates is associated with borrowings under our Revolving Credit Facility and our Term Loan, both of which are variable-rate debt. At September 30, 2025, no amounts were outstanding under our Revolving Credit Facility. In April 2025, our previous interest rate swaps expired, and we entered into new interest rate swap agreements to effectively convert $460.0 million of our term loan borrowings from a variable rate to a fixed rate. These interest rate swaps are intended to mitigate the exposure to fluctuations in interest rates and qualify for hedge accounting treatment as cash flow hedges. A 100 basis point increase or decrease in interest rates as of September 30, 2025 would have an insignificant impact on our annual earnings.
Market Price Sensitive Instruments
As discussed in note 9 to the consolidated financial statements during the three months ended September 30, 2025, we redeemed all of the remaining 0.375% Convertible Senior Notes that were previously outstanding and settled all of the related capped calls options. Accordingly, we no longer have any market price sensitive instruments.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures designed to ensure that information required to be disclosed in reports filed under the Securities Exchange Act of 1934 (“the Exchange Act”), as amended, is recorded, processed, summarized and reported within the specified time periods, and that such information is accumulated and communicated to management, including our chief executive officer and chief financial officer, as appropriate, to allow timely decisions regarding required disclosure.
Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of September 30, 2025. Based on the evaluation, our chief executive officer (principal executive officer) and chief financial officer (principal financial officer) concluded that, as of that date, our disclosure controls and procedures were effective.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting during the three months ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
29
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
Information regarding our material pending legal proceedings, if any, is provided in note 12 to the condensed consolidated financial statements in this Form 10-Q and incorporated herein by reference.
Item 1A. Risk Factors
Refer to the “Risks Factors” section in our Annual Report on Form 10-K for the year ended December 31, 2024 for a discussion of risks to which our business, financial condition, results of operations and cash flows are subject. Other than as described below, there have been no material changes to the risk factors disclosed in the aforementioned Annual Report.
Expansion of U.S. tariffs could have a material, adverse effect on our financial results
On September 24, 2025, the U.S. Department of Commerce Bureau of Industry and Security (“BIS”) announced the initiation of an investigation into the effects on U.S. national security of imports of personal protective equipment, medical consumables, and medical equipment, including medical devices such as insulin pumps. BIS is conducting the investigation under Section 232 of the Trade Expansion Act of 1962 (Section 232), a law that empowers the president to restrict imports of products that threaten to impair national security. The investigation could result in overriding the tariff exemption currently in place for certain medical devices, which could have a material impact on our results of operations in future years.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Issuer purchases of Equity Securities
The following table presents information regarding repurchases of our shares of common stock during the three months ended September 30, 2025:
| Fiscal Period | Total Number of Shares Purchased | Average Price Paid per Share | Total Number of Shares Purchased as a Part of Publicly Announced Program | Maximum Dollar Value of Shares that May Yet Be Purchased Under the Program (in millions) | ||||||||||||||||||||||
| 7/1/2025 - 7/31/2025 | $ | — | $ | — | $ | — | $ | 94.9 | ||||||||||||||||||
| 8/1/2025 - 8/31/2025 | $ | 91,268 | $ | 323.78 | $ | 91,268 | $ | 65.4 | ||||||||||||||||||
| 9/1/2025 - 9/30/2025 | $ | — | $ | — | $ | — | $ | 65.4 | ||||||||||||||||||
In March 2025, the Company’s Board of Directors authorized a program to repurchase up to $125 million of common stock through December 31, 2026.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Rule 10b5-1 Plans
On September 11, 2025 , Prem Singh , the Company’s Senior Vice President , Global Operations, adopted a written trading plan intended to satisfy Rule 10b5-1(c) under the Exchange Act to sell up to 3,987 shares of the Company’s common stock between March 16, 2026 and September 11, 2026. The trading plan will cease upon the earlier of September 11, 2026 or the sale of all shares subject to the trading plan.
During the period covered by this Quarterly Report on Form 10-Q, none of our other executive officers and no director of the Company adopted , modified or terminated
30
Item 6. Exhibits
| Number | Description | |||||||
10.1# | ||||||||
31.1* | ||||||||
31.2* | ||||||||
32.1** | ||||||||
| 101 | The following materials from Insulet Corporation’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 formatted in iXBRL (Inline eXtensible Business Reporting Language), as follows: | |||||||
(i) Condensed Consolidated Balance Sheets (Unaudited) as of September 30, 2025 and December 31, 2024 | ||||||||
(ii) Condensed Consolidated Statements of Income (Unaudited) for the three and nine months ended September 30, 2025 and 2024 | ||||||||
(iii) Condensed Consolidated Statements of Comprehensive Income (Unaudited) for the three and nine months ended September 30, 2025 and 2024 | ||||||||
(iv) Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) for the three and nine months ended September 30, 2025 and 2024 | ||||||||
(v) Condensed Consolidated Statements of Cash Flows (Unaudited) for the nine months ended September 30, 2025 and 2024 | ||||||||
| (vi) Condensed Notes (Unaudited) to Consolidated Financial Statements | ||||||||
* | Filed herewith. | |||||||
** | Furnished herewith. | |||||||
# | Management contract or compensation plan | |||||||
31
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.
INSULET CORPORATION (Registrant) | ||||||||
| Date: | November 6, 2025 | /s/ Ashley McEvoy | ||||||
Ashley McEvoy | ||||||||
| Chief Executive Officer (Principal Executive Officer) | ||||||||
| Date: | November 6, 2025 | /s/ Flavia H. Pease | ||||||
Flavia H. Pease | ||||||||
Chief Financial Officer, Executive Vice President (Principal Financial Officer) | ||||||||
32
EXHIBIT 31.1
CERTIFICATION
I, Ashley McEvoy, certify that:
1.I have reviewed this Quarterly Report on Form 10-Q of Insulet Corporation;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| /s/ Ashley McEvoy | ||||||||
| Ashley McEvoy | ||||||||
| Chief Executive Officer | ||||||||
| Date: | November 6, 2025 | |||||||
EXHIBIT 31.2
CERTIFICATION
I, Flavia H. Pease, certify that:
1.I have reviewed this Quarterly Report on Form 10-Q of Insulet Corporation;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
/s/ Flavia H. Pease | ||||||||
Flavia H. Pease | ||||||||
| Chief Financial Officer, Executive Vice President | ||||||||
| Date: | November 6, 2025 | |||||||
EXHIBIT 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, each of the undersigned officers of Insulet Corporation, a Delaware corporation (the “Company”), does hereby certify with respect to the Quarterly Report of the Company on Form 10-Q for the period ended September 30, 2025, as filed with the Securities and Exchange Commission (the “Report”) that, to their knowledge:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| /s/ Ashley McEvoy | ||||||||
| Ashley McEvoy | ||||||||
| Chief Executive Officer | ||||||||
| Date: | November 6, 2025 | |||||||
/s/ Flavia H. Pease | ||||||||
Flavia H. Pease | ||||||||
| Chief Financial Officer, Executive Vice President | ||||||||
| Date: | November 6, 2025 | |||||||