Insulet 10-Q 2026-03-31
Filed 2026-05-06. 8 sections, 103K characters. Original on sec.gov · Markdown · JSON
Cover and table of contents
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 March 31, 2026
OR
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number 001-33462
INSULET CORPORATION
(Exact name of Registrant as specified in its charter)
| Delaware | 04-3523891 | ||||||||||||||||
| (State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) | ||||||||||||||||
| 100 Nagog Park | Acton | Massachusetts | 01720 | ||||||||||||||
| (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.
| Large accelerated filer | ☒ | Accelerated filer | ☐ | |||||||||||
| Non-accelerated filer | ☐ | Smaller reporting company | ☐ | |||||||||||
| Emerging growth company | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
| Common Stock, $0.001 Par Value Per Share | PODD | The NASDAQ Stock Market, LLC |
As of April 29, 2026, the registrant had 69,264,674 shares of common stock outstanding.
TABLE OF CONTENTS
PART I - FINANCIAL INFORMATION
| Item 1. | Condensed Consolidated Financial Statements (Unaudited) |
INSULET CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
| ** |
Showing the first 8K of 61K characters. Open the full section
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, 2025 and in this quarterly report. Columns and rows within tables may not add due to rounding. Amounts have been calculated using actual, non-rounded figures; accordingly, amounts and percentages may not recalculate, and columns and rows within tables may not add due to rounding.
Overview
Our mission is to transform 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 a 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. The Pod currently integrates with Dexcom, Inc.’s G6 and G7 CGMs and with Abbott Diabetes Care, Inc.’s (“Abbott”) FreeStyle Libre 2 Plus sensor (“Libre 2 Plus”) in various markets. 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 continue to roll out Omnipod 5 in additional countries. In February 2026, we launched Omnipod 5 in five counties in the Middle East. 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.
In the U.S., we sell our products through the pharmacy channel, which expands access by improving affordability, as no upfront investment is required. We also continue to increase awareness of Omnipod products through our direct-to-consumer advertising programs.
We continue to focus on our product development efforts, including choice of smartphone integration and CGM with Omnipod 5 and enhancing the customer experience through digital product and data capabilities. We are currently working to integrate Omnipod 5 with Abbott’s FreeStyle Libre 3 Plus (“Libre 3 Plus”) and developing Omnipod 6, our next generation AID product. During the first quarter of 2026, we completed a limited market release in the U.S. of Omnipod 5 algorithm enhancements, including a lower 100mg/dL target glucose set point. In addition, we completed a limited market release of the Omnipod 5 algorithm with Libre 3 Plus in the U.S. We also advanced development of our fully closed-loop AID system for people with type 2 diabetes, including recently enrolling the first participant in our EVOLVE pivotal study to support a planned 510(k) submission in 2027.
Finally, we continue to take steps to strengthen our global manufacturing capabilities, which includes investing in a new manufacturing plant in Costa Rica to support our continued growth.
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
| Three Months Ended March 31, | |||||||||||||||||||||||||||||
| (dollars in millions) | 2026 | 2025 | Percent Change | Currency Impact | Constant Currency**(1)** | ||||||||||||||||||||||||
| U.S. | $ | 515.6 | $ | 401.7 | 28.3 | % | — | % | 28.3 | % | |||||||||||||||||||
| International | 242.9 | 152.3 | 59.4 | % | 14.2 | % | 45.2 | % | |||||||||||||||||||||
| Total Omnipod Products | 758.4 | 554.0 | 36.9 | % | 3.9 | % | 33.0 | % | |||||||||||||||||||||
| Drug Delivery | 3.3 | 14.9 | (77.9) | % | — | % | (77.9) | % | |||||||||||||||||||||
| Total | $ | 761.7 | $ | 569.0 | 33.9 | % | 3.8 | % | 30.1 | % |
(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 March 31, 2026 increased $192.8 million, or 33.9%, to $761.7 million, compared with $569.0 million for the three months ended March 31, 2025. Constant currency revenue growth of 30.1% for the three months ended March 31, 2026 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 $113.9 million, or 28.3%, to $515.6 million for the three months ended March 31, 2026, compared with $401.7 million for the three months ended March 31, 2025. This increase primarily resulted from higher sales volume driven by growing our customer base.
As discussed in note 1 to our consolidated financial statements, revenue from the sale of Omnipod products in the U.S. for the three months ended March 31, 2025 included $148.5 million of sales to a related party.
For full year 2026, 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 $90.5 million, or 59.4%, to $242.9 million for the three months ended March 31, 2026, compared with $152.3 million for the three months ended March 31, 2025. Excluding the 14.2% favorable impact of currency exchange, the remaining 45.2% increase in revenue was primarily due to higher volumes from our growing customer base, and to a lesser extent, a higher average selling price for Omnipod 5, compared with Omnipod DASH.
For full year 2026, we expect higher International Omnipod revenue due to continued volume growth driven by new customers and higher price resulting from conversions to Omnipod 5.
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 $3.3 million and $14.9 million for the three months ended March 31, 2026 and 2025, respectively.
Costs and Expenses
| Three Months Ended March 31, | |||||||||||||||||||||||
| 2026 | 2025 | ||||||||||||||||||||||
| (dollars in millions) | Amount | Percent of Revenue | Amount | Percent of Revenue | |||||||||||||||||||
| Cost of revenue | $ | 232.7 | 30.5 | % | $ | 159.9 | 28.1 | % | |||||||||||||||
| Research and development expenses | $ | 89.7 | 11.8 | % | $ | 59.6 | 10.5 | % | |||||||||||||||
| Selling, general and administrative expenses | $ | 317.2 | 41.6 | % | $ | 260.7 | 45.8 | % |
Cost of Revenue
Cost of revenue for the three months ended March 31, 2026 increased $72.7 million, or 45.5%, to $232.7 million, compared with $159.9 million for the three months ended March 31, 2025. Gross margin was 69.5% for the three months ended March 31, 2026, compared with 71.9% for the three months ended March 31, 2025. The 240 basis point decrease in gross margin was primarily driven by an increase in inventory excess and obsolescence reserve as we transition to our new Pod configurations and, to a lesser extent, higher warranty costs resulting from the voluntary medical device correction we issued in March 2026 related to specific lots of
Omnipod 5 Pods. These decreases in gross margin were partially offset by improved manufacturing efficiencies and a higher average selling price.
We estimate the voluntary medical device correction and related costs will be approximately $30 million, more than half of which we expect to incur in 2026, with the remainder expected to be incurred in 2027. The latter relates to incremental manual quality inspections expected to be performed until automated inspection systems are implemented. We do not expect tariffs to have a significant impact on our gross margin in 2026; however, the elimination of the current exemption for certain medical devices 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 March 31, 2026 increased $30.1 million, or 50.6%, to $89.7 million, compared with $59.6 million for the three months ended March 31, 2025. Research and development expenses as a percent of revenue was 11.8% and 10.5% for the three months ended March 31, 2026 and 2025, respectively. The increase in research and development expenses were primarily due to continued investment in our Omnipod and pipeline products, including a fully closed-loop AID system for type 2 diabetes and Omnipod 6, our next generation AID system.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the three months ended March 31, 2026 increased $56.6 million, or 21.7%, to $317.2 million, compared with $260.7 million for the three months ended March 31, 2025. The increase in selling, general and administrative expenses were primarily attributable to year-over-year headcount additions, mainly in our commercial and customer experience teams, to support our market share gains and customer retention. Commercial investments, including international market development and demand generation also contributed to the increase in selling, general and administrative expenses, although to a lesser extent. We expect to continue investing in sales and marketing to expand our sales force and prepare for upcoming product launches, including the full market release with Omnipod 5 algorithm integrated with Libre 3 Plus and our latest algorithm enhancements.
Non-Operating Items
Interest Expense and Income
Interest expense increased $5.5 million to $14.7 million for the three months ended March 31, 2026, compared with $9.2 million for the three months ended March 31, 2025 primarily due to the issuance of 6.5% senior unsecured notes in March 2025 and the renewal of interest rate swaps at higher rates in April 2025.
Interest income decreased $5.3 million to $4.9 million for the three months ended March 31, 2026, compared with $10.3 million for the three months ended March 31, 2025. The decrease in interest income was driven by lower average cash balances and, to a lesser extent, lower average interest rates.
We expect net interest expense for the full year 2026 to increase to approximately $40 million, primarily due to lower interest income.
Loss on Extinguishment of Debt
During three months ended March 31, 2025, the Company repurchased $125.2 million in principal ($124.5 million net of issuance costs) of Convertible Senior Notes for $162.5 million in cash, which resulted in a $39.5 million loss on extinguishment.
Income Tax Expense
Our effective tax rate was 19.4% for the three months ended March 31, 2026, compared with 26.4% for the three months ended March 31, 2025. The decrease in the effective tax rate was primarily due to non-deductible charges from the extinguishment of convertible debt during the three months ended March 31, 2025, as well as changes in the distribution of earnings among the jurisdictions in which we operate.
The Organization for Economic Co-operation and Development (“OECD”) and participating countries continue to advance the implementation of a 15% global minimum corporate tax (“Pillar Two”). Certain jurisdictions in which we operate, including the Netherlands and the United Kingdom, enacted legislation implementing aspects of Pillar Two during 2025. In January 2026, the OECD issued additional administrative guidance introducing a “side-by-side” framework applicable to U.S.-parented multinational groups, which is expected to reduce the extent to which certain Pillar Two charging provisions, including the Income Inclusion Rule and the Undertaxed Profits Rule, apply. Notwithstanding this guidance, we remain subject to Qualified Domestic Minimum Top-Up Taxes enacted by certain jurisdictions. We expect ongoing legislative developments and additional administrative guidance related to Pillar Two throughout 2026. Pillar Two did not have a material impact on our consolidated financial statements for the three months ended March 31, 2026; however, we continue to monitor developments and evaluate the potential impact of this legislation on future periods.
During 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, changes to the international tax framework, and the restoration of favorable tax treatment for certain business provisions. The legislation includes multiple effective dates for various provisions through 2027. Our effective tax rate for 2026 is affected by changes to the allocation of research and development expenses for purposes of the Foreign-Derived Deduction-Eligible Income (“FDDEI”), as well as other international tax reforms enacted under OBBBA. The effects of the legislation were not material to our consolidated financial statements for the three months ended March 31, 2026.
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 March 31, | |||||||||||
| (in millions) | 2026 | 2025 | |||||||||
| Net income | $ | 91.1 | $ | 35.4 | |||||||
| Interest expense (income), net | 9.8 | (1.1) | |||||||||
| Income tax expense | 21.9 | 12.7 | |||||||||
| Depreciation and amortization | 26.2 | 21.7 | |||||||||
| Stock-based compensation expense | 21.3 | 18.2 | |||||||||
| Loss on extinguishment of debt(1) | — | 39.5 | |||||||||
| Voluntary medical device correction(2) | 11.7 | — | |||||||||
| CFO transition(3) | (0.3) | — | |||||||||
| Loss on investments(4) | — | 7.5 | |||||||||
| Adjusted EBITDA | $ | 181.7 | $ | 133.9 |
(1) Relates to the repurchase of a portion of our convertible debt.
(2) Represents estimated warranty costs associated with the voluntary medical device correction in March 2026, which are included in cost of revenue. Refer to note 7 to the consolidated financial statements for additional information.
(3) Represents adjustment to the severance benefits for our former Chief Financial Officer.
(4) 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, 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 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
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.
Summary of Cash Flows
| Three Months Ended March 31, | |||||||||||
| (in millions) | 2026 | 2025 | |||||||||
| Cash provided by (used in): | |||||||||||
| Operating activities | $ | 113.8 | $ | 63.8 | |||||||
| Investing activities | (27.7) | (15.6) | |||||||||
| Financing activities | (319.9) | 277.7 | |||||||||
| Effect of exchange rate changes on cash and cash equivalents | (1.9) | 3.8 | |||||||||
| Net (decrease) increase in cash and cash equivalents | $ | (235.7) | $ | 329.7 |
Operating Activities
Net cash provided by operating activities of $113.8 million for the three months ended March 31, 2026 was primarily attributable to net income, as adjusted for depreciation and amortization, stock-based compensation expense, and deferred income taxes, partially offset by a $32.3 million working capital outflow. The working capital outflow was driven by a $69.3 million decrease in accrued expenses and other liabilities and a $30.6 million increase in accounts receivable, partially offset by a $71.4 million increase in accounts payable. The decrease in accrued expenses and other liabilities was primarily driven by the annual payout of cash bonuses for performance in the prior year. The increases in accounts receivable and payable were primarily due to an increase in sales driven by our growing customer base and the timing of payments, respectively.
Investing Activities
Net cash used in investing activities was $27.7 million for the three months ended March 31, 2026, compared with $15.6 million for the three months ended March 31, 2025.
Capital Spending—Capital expenditures were $24.3 million for the three months ended March 31, 2026, compared with $12.3 million for the three months ended March 31, 2025. The $12.0 million increase primarily related to the purchase of machinery, equipment and tooling for our existing manufacturing facilities and initial investment in our Costa Rica manufacturing plant. We expect capital expenditures for 2026 to increase compared with 2025 to support our continued global manufacturing expansion plans. We expect to fund our capital expenditures using existing cash and financing.
Financing Activities
Net cash used in financing activities was $319.9 million for the three months ended March 31, 2026, compared with net cash provided by financing activities of $277.7 million for the three months ended March 31, 2025.
Debt Issuance and Repayments—During the three months ended March 31, 2025, we received net proceeds of $440.7 million from the issuance of Senior Unsecured Notes and used the proceeds along with proceeds of $23.1 million from the unwinding the related capped call options to partially fund the $163.9 million repurchase of a portion of our Convertible Senior Notes.
Proceeds and Repayments from Secured Borrowing—During the three months ended March 31, 2025, we received $15.4 million of cash advances from a third-party to whom we outsourced our insurance claim submissions process in a certain country. Additionally, we repaid $13.4 million of cash advances during the three months ended March 31, 2025.
*Payment of Taxes for Restricted Stock Net Settlements—*Payments for taxes related to net restricted and performance stock unit settlements were $15.7 million and $21.2 million for the three months ended March 31, 2026 and 2025, respectively. The $5.5 million decrease was primarily driven by tax payments related to the vesting of performance and restricted stock units for a former executive in the prior year.
*Repurchase of Common Stock—*During the three months ended March 31, 2026, we paid $300.0 million to repurchase common shares pursuant to accelerated share repurchase agreements discussed under “Capitalization—Share Repurchase Program.”
Free Cash Flow
Free cash flow was $89.5 million for the three months ended March 31, 2026, compared with $51.6 million for the three months ended March 31, 2025. The $38.0 million increase in free cash flow primarily resulted from an increase in operating income as adjusted for depreciation, amortization, and stock-based compensation expense, and a decrease in working capital outflow, partially offset by an increase in capital expenditures.
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:
| Three Months Ended March 31, | |||||||||||
| (in millions) | 2026 | 2025 | |||||||||
| Net cash provided by operating activities | $ | 113.8 | $ | 63.8 | |||||||
| Capital expenditures | (24.3) | (12.3) | |||||||||
| Free cash flow | $ | 89.5 | $ | 51.6 |
Capitalization
The following table contains several key measures to gauge our financial condition and liquidity at the end of each period:
| (dollars in millions) | March 31, 2026 | December 31, 2025 | ||||||||||||
| Cash and cash equivalents | $ | 480.4 | $ | 716.1 | ||||||||||
| Current portion of long-term debt | $ | 18.6 | $ | 18.4 | ||||||||||
| Long-term debt, net | $ | 929.5 | $ | 930.8 | ||||||||||
| Total debt, net | $ | 948.1 | $ | 949.2 | ||||||||||
| Total stockholders’ equity | $ | 1,302.6 | $ | 1,515.2 | ||||||||||
| Debt-to-total capital ratio | 42 | % | 39 | % | ||||||||||
| Net debt-to-total capital ratio | 21 | % | 9 | % |
Credit Agreement
We have a $500 million senior secured revolving credit facility (the “Revolving Credit Facility”), which expires in 2030. At March 31, 2026, 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
Our 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, none of which we consider restrictive to our operations.
Share Repurchase Program
In February 2026, the Board of Directors extended our $125 million share repurchase program to December 31, 2027 and approved an additional $350 million in repurchases of common stock. Additionally, in February 2026, we entered into accelerated share repurchase agreements (“ASRs”) to repurchase $300 million of our common stock, which were completed by March 31, 2026. During the three months ended March 31, 2026, we repurchased approximately 1.25 million shares of common stock.
Commitments and Contingencies
Contractual Obligations
In 2026, we entered into a purchase agreement with NXP USA, Inc. pursuant to which we are committed to purchasing semi-conductor chips for approximately $96.9 million as of March 31, 2026.
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, 2025.
Accounting Standards Issued and Not Yet Adopted
Information regarding accounting standards that have been issued but not yet adopted is provided in note 1 to the condensed consolidated financial statements.
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,” “would,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “risk” or “continue” or the negative of these terms or other similar words or expressions. 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 any expansion 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 endorsements by diabetes associations or other organizations that are unfavorable;
-
our ability to protect our 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, including the war with Iran as well as risks associated with any future pandemic, including supply chain disruptions;
-
the potential violation of anti-bribery/anti-corruption laws;
-
the concentration of manufacturing operations and storage of inventory in a limited number of locations;
-
the regulatory requirements and overall complexity in manufacturing our product and challenges associated with starting new manufacturing lines;
-
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, data protection and artificial intelligence laws;
-
adverse regulatory or legal actions relating to current or future Omnipod products;
-
potential adverse impacts resulting from a recall, or discovery of product safety issues, including potential adverse impacts relating to our recent medical device correction;
-
breaches or failures of our product or information technology systems, including by cyberattack;
-
our ability to maintain the privacy and security of Company and third-party information;
-
our ability to attract, motivate, and retain key personnel;
-
risks associated with potential future acquisitions or investments in new businesses;
-
our ability to raise additional funds on acceptable terms or at all;
-
restrictions imposed by our Credit Agreement; 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, 2025 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.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
There were no material changes to our quantitative and qualitative disclosures about market risk during the three months ended March 31, 2026. 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, 2025 for a discussion of our interest rate and foreign currency exchange risks.
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 March 31, 2026. 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 March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
Information regarding our material pending legal proceedings, if any, is provided in note 11 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, 2025 for a discussion of risks to which our business, financial condition, results of operations, and cash flows are subject. There have been no material changes to the risk factors disclosed in the aforementioned Annual Report.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Issuer purchases of Equity Securities
In February 2026, the Board of Directors extended our $125 million share repurchase program to December 31, 2027 and approved an additional $350 million in repurchases of common stock.
The following table presents information regarding repurchases of our shares of common stock during the three months ended March 31, 2026:
| Fiscal Period | Total Number of Shares Purchased | Average Price Paid per Share (1) | 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) | ||||||||||||||||||||||
| 1/1/2026 - 1/31/2026 | $ | — | $ | — | $ | — | $ | 415.4 | ||||||||||||||||||
| 2/1/2026 - 2/28/2026 | $ | 992,186 | $ | 241.89 | $ | 992,186 | $ | 175.4 | ||||||||||||||||||
| 3/1/2026 - 3/31/2026 | $ | 258,358 | $ | 232.15 | $ | 258,358 | $ | 115.4 |
(1) Average price paid per share excludes excise tax due under the Inflation Reduction Act of 2022.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Rule 10b5-1 Plans
During the first quarter of 2026, no director or executive officer 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.
Item 6. Exhibits
| Number | Description | |||||||
| 10.1*# | Separation Agreement between Insulet Corporation and Ana Chadwick, dated February 10, 2026. | |||||||
| 10.2*# | Offer Letter between Michael Panos and Insulet Corporation, dated March 9, 2026. | |||||||
| 31.1* | Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 by Chief Executive Officer. | |||||||
| 31.2* | Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 by Chief Financial Officer. | |||||||
| 32.1** | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, by Chief Executive Officer and Chief Financial Officer. | |||||||
| 101 | The following materials from Insulet Corporation’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 formatted in iXBRL (Inline eXtensible Business Reporting Language), as follows: | |||||||
| (i) Condensed Consolidated Balance Sheets (Unaudited) as of March 31, 2026 and December 31, 2025 | ||||||||
| (ii) Condensed Consolidated Statements of Income (Unaudited) for the three months ended March 31, 2026 and 2025 | ||||||||
| (iii) Condensed Consolidated Statements of Comprehensive Income (Unaudited) for the three months ended March 31, 2026 and 2025 | ||||||||
| (iv) Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) for the three months ended March 31, 2026 and 2025 | ||||||||
| (v) Condensed Consolidated Statements of Cash Flows (Unaudited) for the three months ended March 31, 2026 and 2025 | ||||||||
| (vi) Condensed Notes (Unaudited) to Consolidated Financial Statements | ||||||||
| * | Filed herewith. | |||||||
| ** | Furnished herewith. | |||||||
| # | Management contract or compensation plan | |||||||
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: | May 6, 2026 | /s/ Ashley A. McEvoy | ||||||
| Ashley A. McEvoy | ||||||||
| Chief Executive Officer (Principal Executive Officer) |
| Date: | May 6, 2026 | /s/ Flavia H. Pease | ||||||
| Flavia H. Pease | ||||||||
| Chief Financial Officer, Executive Vice President (Principal Financial Officer) |