Insulet 10-Q 2025-03-31

Filed 2025-05-09. 8 sections, 124K 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, 2025

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)


Delaware04-3523891
(State or Other Jurisdiction of Incorporation or Organization)(I.R.S. Employer Identification No.)
100 Nagog ParkActonMassachusetts01720
(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, or a smaller reporting 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 classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.001 Par Value Per SharePODDThe NASDAQ Stock Market, LLC

As of May 1, 2025, the registrant had 70,374,923 shares of common stock outstanding.

TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements (Unaudited)3
Condensed Consolidated Balance Sheets (Unaudited) as of March 31, 2025 and December 31, 20243
Condensed Consolidated Statements of Income (Unaudited) for the three months ended March 31, 2025 and 20244
Condensed Consolidated Statements of Comprehensive Income (Unaudited) for the three months ended March 31, 2025 and 20245
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) for the three months ended March 31, 2025 and 20246
Condensed Consolidated Statements of Cash Flows (Unaudited) for the three months ended March 31, 2025 and 20247
Notes to Condensed Consolidated Financial Statements (Unaudited)8
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations19
Item 3. Quantitative and Qualitative Disclosures About Market Risk26
Item 4. Controls and Procedures26
PART II. OTHER INFORMATION
Item 1. Legal Proceedings28
Item 1A. Risk Factors28
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds28
Item 3. Defaults Upon Senior Securities28
Item 4. Mine Safety Disclosures28
Item 5. Other Information28
Item 6. Exhibits29
Signatures30

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)**March 31, 202

Showing the first 8K of 71K 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, 2024 and in this quarterly report.

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, 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.

We also 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.

Results of Operations

Factors Affecting Operating Results

Our Pods are 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)20252024Percent ChangeCurrency ImpactConstant Currency (1)
U.S. Omnipod$401.7$317.726.4%—%26.4%
International Omnipod152.4115.332.2%(3.9)%36.1%
Total Omnipod554.1433.028.0%(1.0)%29.0%
Drug Delivery14.98.771.3%—%71.3%
Total revenue$569.0$441.728.8%(1.0)%29.8%

(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, 2025 increased $127.3 million, or 28.8%, to $569.0 million, compared with $441.7 million for the three months ended March 31, 2024. Constant currency revenue growth of 29.8% was primarily driven by higher sales volume largely attributable to our growing customer base and, to a lesser extent, an increase in inventory days on hand at distributors.

U.S.

Revenue from the sale of Omnipod products in the U.S. increased $84.0 million, or 26.4%, to $401.7 million for the three months ended March 31, 2025, compared with $317.7 million for the three months ended March 31, 2024. This increase primarily resulted from higher sales volume driven by growing our customer base, and, to a lesser extent, the impact of the acceleration of orders by pharmacy wholesalers in the fourth quarter of 2023 in advance of the implementation of our new ERP system on January 1, 2024. These increases were somewhat offset by a decrease in price associated with timing of rebates.

Revenue from the sale of Omnipod products in the U.S. for the three months ended March 31, 2025 included $148.5 million of related party revenue, compared with $111.8 million for the three months ended March 31, 2024. The $36.7 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 $37.1 million, or 32.2%, to $152.4 million for the three months ended March 31, 2025, compared with $115.3 million for the three months ended March 31, 2024. Excluding the 3.9% unfavorable impact of currency exchange, the remaining 36.1% increase in revenue was primarily due to higher volumes from our growing customer base, largely resulting from the prior year launches of Omnipod 5 and, to a lesser extent, from an increase in estimated inventory days-on-hand at distributors to support our 2025 Omnipod 5 launches. A higher average selling price for Omnipod 5, compared with Omnipod DASH and Classic Omnipod, 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 France and the Netherlands, growth from the prior year launches in Germany and the United Kingdom, 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 for the three months ended March 31, 2025 was $14.9 million, compared with $8.7 million for the three months ended March 31, 2024. The increase resulted from an increase in orders from our partner.

Costs and Expenses

Three Months Ended March 31,
20252024
(dollars in millions)AmountPercent of RevenueAmountPercent of Revenue
Cost of revenue$160.028.1%$134.930.5%
Research and development expenses$59.610.5%$50.211.4%
Selling, general and administrative expenses$260.645.8%$199.745.2%

Cost of Revenue

Cost of revenue for the three months ended March 31, 2025 increased $25.1 million, or 18.6%, to $160.0 million, compared with $134.9 million for the three months ended March 31, 2024. Gross margin was 71.9% for the three months ended March 31, 2025, compared with 69.5% for the three months ended March 31, 2024. The 240 basis point increase in gross margin was primarily driven by improved manufacturing and supply chain efficiencies and, to a lesser extent, volume.

For full year 2025, we expect gross margin to be approximately 71.0%. We anticipate gross margin to increase compared with 2024 primarily due to improved manufacturing efficiencies and volume and pricing benefits, partially offset by the negative impact of tariffs, which we currently estimate to be approximately 50 basis points; however, 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.

Research and Development Expenses

Research and development expenses for the three months ended March 31, 2025 increased $9.4 million, or 18.7%, to $59.6 million, compared with $50.2 million for the three months ended March 31, 2024. The increase in research and development expense was 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 clinical trials and our Omnipod and next generation products. Research and development expenses as a percent of revenue decreased to 10.5% in 2025, compared with 11.4% in 2024 primarily due to an increase in sustaining costs for Omnipod 5, which are included in selling, general and administrative expenses. 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 March 31, 2025 increased $60.9 million, or 30.5%, to $260.6 million, compared with $199.7 million for the three months ended March 31, 2024. This increase was primarily attributable to year-over-year headcount additions to enhance customer product support, support our business growth, and engineering support for enhancements to our products. To a lesser extent, the increase was due to an increase in advertising expense.

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 product support, sales, quality and regulatory support, international expansion and engineering support to facilitate continued growth globally. We also plan to make additional investments to 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 decreased $1.5 million to $9.2 million for the three months ended March 31, 2025, compared with $10.7 million for the three months ended March 31, 2024 primarily due to lower monthly interest expense from our Term Loan B and fees paid to amend our Term Loan B in the prior year, which did not repeat in the current year. Interest income was $10.3 million for the three months ended March 31, 2025, compared with $9.4 million for the three months ended March 31, 2024. An increase in average cash balances was mostly offset by a decrease in average interest rates.

Other Expense, net

For the three months ended March 31, 2025, other expense, net increased $1.6 million to $2.3 million, compared with $0.7 million for the three months ended March 31, 2024 driven by a $2.8 million impairment of an equity investment.

Income Tax (Expense) Benefit

Our effective tax rate was 26.4% for the three months ended March 31, 2025, compared with 6.2% for the three months ended March 31, 2024. The increase in the effective tax rate was primarily due to non-deductible charges from the extinguishment of a portion of our convertible debt, partially offset by windfall tax benefits from employee stock-based compensation. In addition, the existence of a full valuation allowance against deferred tax assets in the prior year, most of which was released during the three months ended June 30 2024, contributed to the changes in effective tax rate.

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 three months ended March 31, 2025. We are continuing to evaluate the potential impact on future periods.

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)20252024
Net income$35.4$51.5
Interest expense (income), net(1.1)1.3
Income tax (benefit) expense12.73.4
Depreciation and amortization21.718.8
Stock-based compensation18.214.2
Loss on extinguishment of debt(1)39.5—
Loss on investments(2)7.5—
Adjusted EBITDA$133.9$89.2
(1) Relates to the repurchase of a portion of our convertible debt.
(2) Represents a provision for credit loss included in selling, general and administrative expenses related to a debt investment and an impairment included in other expense related to an equity investment.

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

During the three months ended March 31, 2025, we entered into a purchase agreement with NXP USA, Inc. pursuant to which we committed to purchasing semi-conductor chips for $71.6 million in 2025. See note 9 for information on the debt transactions that were executed during the three months ended March 31, 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:

(in millions)March 31, 2025December 31, 2024
Cash and cash equivalents$1,283.1$953.4
Current portion of long-term debt$83.1$83.8
Long-term debt, net$1,612.3$1,296.1
Total debt, net$1,695.4$1,379.9
Total stockholders’ equity$1,330.7$1,211.6
Debt-to-total capital ratio56%53%
Net debt-to-total capital ratio14%16%

Convertible Debt

To finance our operations and global expansion, we have periodically issued convertible senior notes, which are convertible into our common stock. As discussed in note 9, in March and April 2025, we repurchased $420 million in principal of our Convertible Senior Notes. Subsequent to these transactions, the following Convertible Senior Notes were outstanding:

Issuance DateCouponPrincipal Outstanding (in millions)Due DateConversion Rate (1)Conversion Price per Share of Common Stock
September 20190.375%$380.0September 20264.4105$226.73

(1) Per $1,000 face value of notes

Credit Agreement

We have a $500 million senior secured revolving credit facility (the “Revolving Credit Facility”), which expires in 2030. At March 31, 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.

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.

Summary of Cash Flows

Three Months Ended March 31,
(in millions)20252024
Cash provided by (used in):
Operating activities$63.8$87.6
Investing activities(15.7)(24.0)
Financing activities277.8(14.1)
Effect of exchange rate changes on cash and cash equivalents3.8(2.5)
Net increase in cash, cash equivalents and restricted cash$329.7$47.0

Operating Activities

Net cash provided by operating activities of $63.8 million for the three months ended March 31, 2025 was primarily attributable to net income, as adjusted for loss on extinguishment of debt, depreciation and amortization, and stock-based compensation expense, partially offset by a $65.0 million working capital outflow. The working capital outflow was driven by a $48.7 million decrease in accrued expenses and other liabilities, a $33.4 million increase in accounts receivable, a $12.8 million increase in prepaid expenses and other assets, and a $6.6 million increase in inventories, partially offset by a $36.5 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, partially offset by an increase in accrued rebates primarily due to higher revenue subject to pharmacy rebates. 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 raw materials. The increase in inventories was primarily due to a planned inventory build to satisfy our growing demand. Finally, the increase in accounts payable was driven by the timing of payments.

Investing Activities

Net cash used in investing activities was $15.7 million for the three months ended March 31, 2025, compared with $24.0 million for the three months ended March 31, 2024.

Capital Spending—Capital expenditures were $12.3 million for the three months ended March 31, 2025, compared with $22.1 million for the three months ended March 31, 2024. The $9.8 million decrease primarily related to the purchase of machinery, equipment and tooling during three months ended March 31, 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 and optimize our manufacturing and supply chain operations as well as support our global expansion. We expect to fund our capital expenditures using existing cash.

Investments in Developed Software—Investments in developed software were $3.4 million and $1.9 million for the three months ended March 31, 2025 and 2024, respectively, and primarily related to investments in projects to support our cloud-based capabilities.

Financing Activities

Net cash provided by financing activities was $277.8 million for the three months ended March 31, 2025, compared with net cash used in financing activities of $14.1 million for the three months ended March 31, 2024.

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 $163.9 million of the proceeds to partially fund the repurchase of a portion of our Convertible Senior Notes. In addition, we received net proceeds of $23.1 million from the unwinding of a portion of the capped call options associated with the Convertible Notes. Additionally, during the three months ended March 31, 2025, we made $5.4 million in aggregate principal payments on our equipment financings, Term Loan B, and mortgage, compared with $9.1 million during the three months ended March 31, 2024.

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 outsource 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.

Finance Lease Repayments—During the three months ended March 31, 2024, we made finance lease repayments associated with our Malaysia manufacturing facility totaling $5.8 million.

*Proceeds from Option Exercises—*Proceeds from option exercises were $2.5 million and $5.8 million for the three months ended March 31, 2025 and 2024, respectively. The $3.3 million decrease was primarily driven by option exercises by former executives in the prior year.

*Payment of Taxes for Restricted Stock Net Settlements—*Payments for taxes related to net restricted and performance stock unit settlements were $21.2 million and $5.0 million for the three months ended March 31, 2025 and 2024, respectively. The $16.2 million increase was primarily driven by a higher fair market value of the restricted stock units that vested during the period.

Free Cash Flow

Free cash flow was $51.5 million in the three months ended March 31, 2025, compared with $65.5 million in the three months ended March 31, 2024. 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)20252024
Net cash provided by operating activities$63.8$87.6
Capital expenditures(12.3)(22.1)
Free cash flow$51.5$65.5

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 revenue recognition, income taxes, product warranty and inventory reserves 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 beginning with our annual filing for 2025, as required. The guidance may be applied prospectively or retrospectively.

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 November 2024, the FASB issued ASU 2024-04, Debt—Debt with Conversion and Other Options (Subtopic 470-20), which clarifies the requirements for determining whether certain settlements of convertible debt instruments should be accounted for as an induced conversion. The adoption of ASU 2024-04 is not expected to impact our consolidated financial statements because we expect to repurchase our remaining convertible debt prior to the required January 2026 adoption date.

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:

  • 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;

  • international regulatory, commercial and logistics business risks, including the implementation of tariffs;

  • 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;

  • changes in tax laws or exposure to significant tax liabilities; and

  • risks related to the conversion of outstanding Convertible Senior Notes.

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.

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 interest rate, market price sensitive instruments and foreign currency exchange risk.

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, 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 March 31, 2025 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 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. 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

None.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

Rule 10b5-1 Plans

On March 14, 2025, Prem Singh, 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 4,992 shares of our common stock between June 13, 2025 and March 13, 2026. The trading plan will cease upon the earlier of March 13, 2026 or the sale of all shares subject to the trading plan.

On March 14, 2025, Daniel Manea, Senior Vice President and Chief Human Resources Officer, adopted a written trading plan intended to satisfy Rule 10b5-1(c) under the Exchange Act to sell up to 1,300 shares of our common stock between June 13, 2025 and March 12, 2026. The trading plan will cease upon the earlier of March 12, 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.

Item 6. Exhibits

NumberDescription
4.1Indenture, dated as of March 20, 2025, between Insulet Corporation and Computershare Trust Company, National Association, as Trustee (Incorporated by reference to Exhibit 4.1 to our Current Report on Form 8-K filed March 21, 2025).
10.1#Form of Insulet Corporation 2017 Stock Option and Incentive Plan Non-Qualified Stock Option Agreement (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed February 21, 2025)
10.2#Form of Insulet Corporation 2017 Stock Option and Incentive Plan Restricted Stock Unit Agreement (Incorporated by reference to Exhibit 10.2 to our Current Report on Form 8-K filed February 21, 2025)
10.3#Form of Insulet Corporation 2017 Stock Option and Incentive Plan Performance Stock Unit Agreement (Incorporated by reference to Exhibit 10.3 to our Current Report on Form 8-K filed February 21, 2025)
10.4+Addendum, effective January 1, 2025, to the Purchase Agreement by and between Insulet Corporation and NXP USA, Inc., dated October 12, 2017 (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed March 10, 2025).
10.5Seventh Amendment to Credit Agreement, dated March 20, 2025, among Insulet Corporation, Insulet MA Securities Corporation, Morgan Stanley Senior Funding, Inc., as administrative agent, swingline lender, and letter of credit issuer, and the other lenders party thereto (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed March 21, 2025).
10.6Form of Unwind Agreement (Incorporated by reference to Exhibit 10.2 to our Current Report on Form 8-K filed March 21, 2025)
10.7#Consulting Services Agreement by and between the Company and Mark Field, effective March 14, 2025 (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K/A filed April 9, 2025)
10.8#Offer Letter between Ashley McEvoy and Insulet Corporation, dated April 28, 2025 (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed April 28, 2025)
10.9#Separation Agreement between James R. Hollingshead and Insulet Corporation, dated April 28, 2025 (Incorporated by reference to Exhibit 10.2 to our Current Report on Form 8-K filed April 28, 2025)
10.10#Amended and Restated Executive Severance Plan, dated April 28, 2025 (Incorporated by reference to Exhibit 10.3 to our Current Report on Form 8-K filed April 28, 2025)
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.
101The following materials from Insulet Corporation’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 formatted in iXBRL (Inline eXtensible Business Reporting Language), as follows:
(i) Condensed Consolidated Balance Sheets (Unaudited) as of March 31, 2025 and December 31, 2024
(ii) Condensed Consolidated Statements of Income (Unaudited) for the three months ended March 31, 2025 and 2024
(iii) Condensed Consolidated Statements of Comprehensive Income (Unaudited) for the three months ended March 31, 2025 and 2024
(iv) Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) for the three months ended March 31, 2025 and 2024
(v) Condensed Consolidated Statements of Cash Flows (Unaudited) for the three months ended March 31, 2025 and 2024
(vi) Condensed Notes (Unaudited) to Consolidated Financial Statements
#Management contract or compensation plan.
+Certain portions of this exhibit are considered confidential and have been omitted as permitted under SEC rules and regulations.
*Filed herewith.
**Furnished herewith.

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

INSULET CORPORATION (Registrant)
Date:May 8, 2025/s/ Ashley McEvoy
Ashley McEvoy
Chief Executive Officer (Principal Executive Officer)
Date:May 8, 2025/s/ Ana M. Chadwick
Ana M. Chadwick
Chief Financial Officer, Executive Vice President (Principal Financial Officer)