Insulet 10-Q 2025-09-30

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-Q

For the quarterly period ended September 30, 2025

OR

Commission File Number 001-33462

INSULET CORPORATION

(Exact name of Registrant as specified in its charter)

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.

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:

As of October 30, 2025, the registrant had 70,346,898 shares of common stock outstanding.

TABLE OF CONTENTS

PART I - FINANCIAL INFORMATION

INSULET CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

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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.

Revenue

(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.

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

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.

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.

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”):

(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.

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:

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

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.

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:

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.

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.

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.

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.

PART II - OTHER INFORMATION

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.

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:

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.

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 a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement” as defined in Item 408(c) of Regulation S-K.

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.