Insulet (PODD) 10-K risk factor changes: FY2024 vs FY2023

- competitive pricing; [removed: and]

If we fail to expand and maintain an effective sales force or successfully develop and maintain our relationships with intermediaries, our business, [removed: prospects] [added: prospects,] and brand may be materially and adversely affected.

If our intermediaries are unwilling or unable to market and sell our products, or if they [added: or our sales force] do not perform to our expectations, we could experience delayed or [removed: reduced market acceptance and sales of our products, which would adversely affect our business, financial condition, and results of operations.]

If demand for our products fluctuates as a result of economic conditions, [removed: competition] [added: competition,] or otherwise, our ability to attract and retain customers could be harmed.

In addition, the form and function of our enterprise information technology systems will need to change and be [added: improved upon as our business needs change.]

We may misjudge the amount of time or resources that will be required to effectively manage any anticipated or unanticipated growth in our business, or we may not be able to manufacture sufficient inventory, or attract, [removed: hire] [added: hire,] and retain sufficient personnel to meet our needs.

If we cannot scale our business appropriately, maintain control over [removed: expenses] [added: expenses,] or otherwise adapt to anticipated and unanticipated growth, our business resources may become strained, we may not be able to deliver our Omnipod products in a timely manner, and our results of operations may be adversely affected.

We expect that sales of our Omnipod products, which, for Omnipod 5, occur only through the pharmacy channel in the [removed: U.S.] [added: United States] and for Omnipod DASH, primarily through the pharmacy channel, will be limited unless a substantial portion of their sales price is paid for by third-party payors, including private insurance companies, health maintenance organizations, preferred provider organizations, federal and state government healthcare agencies, intermediaries, Medicare, [removed: Medicaid] [added: Medicaid,] and other managed care providers.

While we anticipate entering into additional contracts with other intermediaries and third-party payors, we cannot assure [removed: you] that our efforts will be successful, which could limit the availability of Omnipod products.

Efforts to control healthcare costs, including limiting access to care, alternative delivery models, and changes in the methods used to determine reimbursement [removed: scenarios] [added: systems] and rates, are ongoing at the federal and state [removed: government] levels.

[removed: It is possible that the ACA, as currently enacted or as it may] [added: Future changes cannot] be [removed: amended in the future,] [added: predicted with certainty,] and [removed: other healthcare reform measures that] may [removed: be adopted in the future, could] have an adverse effect on our industry and on our ability to maintain or increase sales of any of our products.

We compete with companies that produce insulin pumps, such as [removed: Medtronic, Tandem, The Ypsomed Group] [added: Medtronic] and [removed: Roche Diabetes Care, Inc (“Roche”).][added: Tandem.]

MDI therapy, including smart pens, can be substantially less expensive than pump therapy, and improvements in the effectiveness of MDI therapy may result in fewer people [removed: with insulin-dependent diabetes] [added: than we expect] converting from MDI therapy to pump [removed: therapy than we expect,] [added: therapy,] which could result in price pressure and decreased revenue.

In addition, some of our competitors, such as [removed: Medtronic and Roche,] [added: Medtronic,] are large, well-capitalized companies with more resources than we have.

Any breakthroughs in diabetes monitoring, [removed: treatment] [added: treatment,] or prevention could reduce the potential market for our products or render our products obsolete altogether, which would significantly reduce our sales or cause our sales to grow at a slower rate than we currently expect.

Our [removed: own] new product development initiatives may prove to be ineffective or not commercially successful.

Market acceptance for our new products could be affected by several factors, including the availability of alternative products from our competitors, the price of our products, the timing of our market entry, and our ability to market [removed: and distribute our products effectively.]

Our failure to introduce [added: commercially successful] new and innovative products in a timely manner could have a material adverse effect on our business, results of operations, financial condition, and cash flows.

To help improve, market, and sell our Omnipod products, we have sponsored, and expect to continue to [removed: sponsor] [added: sponsor,] market studies to assess various aspects of the functionality and relative efficacy of our products.

To protect our intellectual property, we may need to assert claims of infringement or misappropriation against third [removed: parties.][added: parties, as we are currently doing in several cases.]

As [removed: our revenue increases,] the number of companies with whom we compete [removed: grows,] [added: grows] and the functionality of products and technology in different industry segments [removed: overlaps,] [added: overlap,] the risk of third-party infringement claims increases.

Third parties may currently have, or may eventually be issued, patents [removed: on which] [added: related to] our current or future products or technologies [removed: may be alleged to infringe.][added: and any of these third parties might make a claim of infringement against us.]

[removed: In addition, such litigation could] cause [removed: negative publicity, adversely affect prospective users, cause] product shipment delays, limit or prohibit us from manufacturing, [removed: marketing] [added: marketing,] or selling our current or future products, and/or require us to develop non-infringing technology, make substantial payments to third parties, or enter into royalty or license agreements, which may not be available on acceptable terms or at all.

We rely on agreements or licenses to intellectual property or other rights in order to sell our current [removed: product] [added: products] and commercialize new products.

[added: For example, we have commercial agreements with Dexcom and Abbott that allow us to sell] Omnipod 5 with integration to Dexcom’s [removed: CGM] and [removed: have a development agreement with Abbott to integrate] Abbott’s CGM [removed: with Omnipod 5.][added: sensors.]

The continuing worldwide macroeconomic and geopolitical uncertainty as well as the impact of [removed: the COVID-19 or other] global pandemics may adversely affect our business and prospects.

Uncertainty about global economic conditions, particularly in countries with government-sponsored healthcare systems, may also cause [added: slower adoption of new technologies such as Omnipod 5, resulting in] decreased demand for our [removed: products, consumers may reduce their spending, new orders for our] products [removed: may decline] and [removed: our] [added: increased competition, downward pricing pressure, and increased] user [removed: attrition rate may increase,] [added: attrition,] which could have a material adverse effect on our business, sales, financial condition, and results of operations.

[removed: Another] [added: In addition, another] global pandemic like COVID-19 [removed: has the potential to] [added: could] significantly impact our supply chain if the manufacturing plants that produce our products or product components, the distribution centers where we manage our inventory, or the operations of our logistics and other service providers, including third parties that sterilize our products, are disrupted, temporarily [removed: closed] [added: closed,] or experience worker shortages for a sustained period of time.

[removed: As a result] [added: Following the onset] of the COVID-19 pandemic, many employees [removed: have] transitioned to a remote or hybrid work environment, which has increased risks associated with our information technology systems and networks.

Our international operations are subject to risks that are inherent in conducting business under foreign laws, [removed: regulations] [added: regulations,] and customs.

International sales made up [removed: 24%] [added: 25%] of our revenues in [removed: 2023] [added: 2024] and we expect international sales to contribute significantly to our future growth as we [added: continue to] launch Omnipod 5 in [removed: our] [added: additional] international markets.

[removed: For example, a] [added: A] significant portion of our products are manufactured by a third-party contract manufacturer in [removed: China.][added: China, and we also manufacture products at our facility in Malaysia.]

Because we do business in the [removed: U.K.,] [added: United Kingdom,] the U.K. Bribery Act also extends to our interaction with public and private sector entities and persons outside the [removed: U.K.,] [added: United Kingdom,] including in the United States.

[removed: While we expect to begin production] [added: Our products are manufactured in three locations:] at our [removed: newly constructed] manufacturing facility in [removed: Malaysia in 2024, currently our products are manufactured in two locations,] [added: the United States,] at our [removed: U.S.] [added: newly constructed] manufacturing facility in [removed: Massachusetts] [added: Malaysia,] and on manufacturing lines owned by us at a facility located in China that is operated by a third-party contract manufacturer.

We take precautions to ensure that our third-party contract manufacturer and logistics entity safeguard our assets, including maintaining [removed: insurance, enacting health and safety protocols, and storing computer data offsite.]

[removed: The] [added: Further, the] insurance we maintain may not be adequate to cover our losses in any particular case.

With or without insurance, damage to our facility, manufacturing equipment, [removed: inventory] [added: inventory,] or other [removed: property] [added: property,] or to any of our suppliers, may have a material adverse effect on our business, financial condition, and results of operations.

- our suppliers may fail to comply with [added: environmental,] conflict minerals, anti-slavery, or other applicable laws, thus impairing our ability to source materials.

An interruption, delay, or inability to obtain components, [removed: products] [added: products,] and raw materials from our third-party suppliers at acceptable prices in a timely manner, could hinder our ability to manufacture our products in a timely or cost-effective manner and have a material adverse effect on our business and results of operations.

While we manufacture our products in the United [removed: States,] [added: States and at our new facility in Malaysia,] a third-party contract manufacturer in China manufactures and supplies a significant portion of our [removed: inventory and we expect to begin additional manufacturing in our new facility in Malaysia during 2024.][added: inventory.]

- failure to appropriately forecast the demand, competition, and costs related to markets in which we compete; and

reduced market acceptance and sales of our products, which would adversely affect our business, financial condition, and results of operations.

and distribute our products effectively.

Companies could produce competing products using the stolen intellectual property and counterfeit products could also be developed.

The latter could be damaging to our reputation if the products do not work properly.

In addition, such litigation could cause negative publicity, adversely affect prospective users,

A weakening of macroeconomic conditions may also adversely affect our suppliers, which could result in interruptions in supply.

In addition, continuing social and political concerns and divisions in the United States and throughout the world, could have a material, adverse effect on the economic conditions in markets we serve, and on our results of operations, cash flow and financial position.

Elections and political changes in various countries, including the United States, may further exacerbate geopolitical and geoeconomic tensions and market instability.

Another global pandemic could adversely impact our business and financial condition.

Our future and existing international operations may subject us to a number of additional risks and expenses, any of which could harm our operating results.

These risks and expenses include:

- currency fluctuation;

In addition, government policies on international trade and investment such as import quotas, capital controls or tariffs, whether adopted by individual governments or addressed by regional trade blocks, can affect the cost of and the demand for our products and services, impact the competitive position of our products, or otherwise adversely affect our ability to sell products in the affected countries.

The implementation of more restrictive trade policies, such as more detailed inspections, higher tariffs, or new barriers to entry, could negatively impact our business, results of operations, and financial condition.

For example, a government's adoption of “buy national” policies or retaliation by another government against such policies could have a negative impact on our results of operations.

insurance, enacting health and safety protocols, and storing computer data offsite.

decrease our gross margins and cause a shortage of product supply.

Failure to scale manufacturing appropriately to meet future demand could also result in product shortages.

A voluntary recall by us could occur as a result of any material deficiency in a

For example, CCPA

Our IT systems are vulnerable to damage, disruptions, or shutdowns due to various factors such as viruses, hacking, power outages, user error, hardware failures, and catastrophic events.

The rapidly-changing technical and regulatory environment and our AI-related activities may have an adverse effect on our business.

We develop and license from other developers, and deploy, AI tools including Generative AI tools for use in our operations.

Our teams collaborate on the development of responsible AI policies and practices and deployment of AI tools in accordance with those policies and practices, which are in turn based on relevant laws and standards, including the EU AI Act (which is taking effect in stages, through August 2026).

While we anticipate being able to capitalize on opportunities using AI tools including Generative AI tools, improving efficiencies and creating more personalized experiences, doing so is not without risk.

Risks include potential inappropriate disclosure of personal information and confidential information and potential use of inaccurate information contained in Generative AI outputs.

As Insulet continues to quickly grow, our success is highly dependent on attracting the right talent, retaining our employees, and keeping them engaged and focused on our mission.

Amidst significant competition for talent, we continue to support our employees working remotely, where feasible.

While this policy aids in recruitment and breadth of candidate pools, it could impact job performance in some cases.

If we are unable to successfully recruit or retain employees as needed, we could experience significant operational disruptions, which could in turn negatively impact our customers, our reputation and our financial condition.

condition, and results of operations could be materially and adversely affected.

Changes in tax laws or exposures to additional tax liabilities could negatively impact our operating results.

We are subject to income taxes, as well as taxes that are not income-based, in both the U.S. and jurisdictions outside of the U.S. Changes in tax laws or regulations in the jurisdictions in which we operate, including the U.S. and as led by the Organization for Economic Cooperation and Development for a global minimum tax, could negatively impact the Company’s effective tax rate, results of operations and cash flows.

In addition, our future effective tax rate could be unfavorably affected by numerous other factors including a change in the interpretation of tax rules and regulations in the jurisdictions in which we operate, a change in our geographic earnings mix, or a change in the measurement of our deferred taxes.

We are also subject to ongoing tax audits in various jurisdictions, and tax authorities may disagree with certain positions we have taken and assess additional taxes.

In 2024, we worked to remediate a material weakness related to the effectiveness of information technology general controls over systems that support our financial reporting outside of North America, which has now been fully remediated.

Market Risk.

See Item 7A for additional risks relating to interest rates, market-sensitive instruments, and foreign currency exchange.

[Table](#i5c5eb5e0e38c49dcae99416b1fdf5f72_7) [of Contents](#i5c5eb5e0e38c49dcae99416b1fdf5f72_7)

improved upon as our business needs change.

During the past several years, the U.S. healthcare industry has been subject to an increase in governmental regulation at both the federal and state levels.

It is unclear how the ACA and its implementation, as well as efforts to repeal or replace, or invalidate, the ACA, or portions thereof, will affect our business.

Additional legislative changes, regulatory changes, and judicial challenges related to the ACA remain possible.

In 2023, for example, ongoing adoption of the GLP-1 class of drugs in diabetes and news surrounding the expansion of use of GLP-1 drugs in obesity led to speculation regarding the impact on the insulin therapy market.

We believe this speculation was the cause of a decline in our stock price in 2023.

Furthermore, our third-party clinical trial investigators may be delayed in conducting our clinical trials for reasons outside of their control.

Any of these third parties might make a claim of infringement against us.

For example, our rights to incorporate the FreeStyle blood glucose meter into Classic Omnipod is governed by a license agreement with Abbott.

In addition, we have a commercial agreement with Dexcom that allows us to sell

In addition to the United States, we sell our products in Europe, Canada, the Middle East and Australia.

If the U.S. dollar strengthens in relation to the currencies of other countries where we sell our products, such as the euro, our U.S. dollar reported revenue and income will decrease.

Changes in the relative values of currencies occur regularly and, in some instances, may have a significant effect on our operating results.

Our efforts to introduce or expand our current or future products in international markets may not be successful, in which case we may have expended significant resources without realizing the expected benefit.

Ultimately, the investment required for expansion into international markets could exceed the results of operations generated from this expansion.

In addition to the risks discussed elsewhere in this Item 1A, other risks associated with doing business internationally, include:

As described elsewhere in this 10-K, in October and November 2022, we issued voluntary Medical Device Corrections (“MDCs”) relating to the batteries and/or charging of our DASH PDMs and Omnipod 5 Controllers, which are manufactured for us by a third-party.

The FDA is in the process of reviewing the 510(k) clearance process and criteria and has announced initiatives to improve the current pre- and post-market regulatory processes and requirements associated with infusion pumps and other home use medical devices.

Any change in the laws or regulations that govern the clearance and approval processes relating to our current and future products could make it more difficult and costly to obtain clearance or approval for new products, or to produce, market, and distribute existing products.

agency could disagree with our characterization of certain statements and conclude that we have engaged in off-label promotion.

In California, the CCPA, which provides certain privacy rights and consumer protection for residents of the state became effective in 2020, and additional regulation under the CPRA, which amends and expands the CCPA, will take effect in 2024.

In 2023, similar privacy laws became effective in Colorado and Virginia.

data of individuals, the information provided to individuals regarding the processing of their personal data, the security and confidentiality of personal data, notifications in the event of data breaches, and use of third-party processors.

The nature of our business involves the receipt and storage of personal and financial information regarding our customers, including sensitive medical information.

Our information technology systems may be susceptible to damage, disruptions, or shutdowns due to computer viruses, attacks by computer hackers, failures during the process of upgrading or replacing software, databases or components thereof, power outages, hardware failures, telecommunication failures, user errors, or catastrophic events.

Additionally, the FDA has warned that insulin pumps may have cybersecurity vulnerabilities and could be manipulated by hackers, causing danger to people with diabetes.

After extensive testing and research in conjunction with an independent third-party firm, a potential security vulnerability in Classic Omnipod was identified.

Successful exploitation of this vulnerability may allow an attacker to gain access to the Pod to intercept, modify, or interfere with the wireless radio frequency communications to or from the PDM.

This may allow attackers to read sensitive data, change pump settings, or control insulin delivery.

Insulet is aware of a specific group of people with diabetes who have been able to duplicate the Pod communication protocol using a smartphone and a bridge, which in turn allows the Pod to be controlled using an unauthorized device.

This practice is commonly referred to as Do-It-Yourself (DIY) and is not the intended use with Omnipod products.

Insulet has not provided the DIY community with any type of information or input on the product, nor has Insulet been provided with any information proving that this form of off-label use is a safe use of the system.

This practice does not exist with Omnipod 5.

We may not be able to generate sufficient cash flow from operations to service our debt, which is substantial.

As of December 31, 2023, we had debt of $1.4 billion, including $800 million aggregate principal amount of Convertible Senior Notes, which mature in 2026.

Our ability to make scheduled payments or to refinance the Convertible Senior Notes or other debt obligations depends on our financial and operating performance, which is subject to prevailing economic and competitive conditions and to certain financial, business, and other factors beyond our control.

If our cash flows and capital resources are insufficient to fund these obligations, we may be forced to reduce or delay capital expenditures, sell assets or operations, seek additional capital, or restructure or refinance our indebtedness, including the outstanding Convertible Senior Notes.

We cannot assure you that we would be able to take any of these actions, that these actions would permit us to meet our scheduled debt service obligations, or that these actions would be permitted under the terms of our future debt agreements.

If we do not generate sufficient cash flow from operations, and additional borrowings, refinancings, or proceeds from asset sales are not available to us, we may not have sufficient cash to enable us to meet all of our obligations.

We are primarily engaged in the development, manufacture, and sale of our proprietary [added: Omnipod product platform, a] continuous insulin delivery system for people with insulin-dependent diabetes.

The Omnipod [removed: platform,] [added: platform] includes: [removed: Classic Omnipod, its next generation Omnipod DASH,] the most recent generation Omnipod 5, and [removed: our latest innovation,] [added: its predecessors] Omnipod [removed: GO, which received U.S. Food] [added: DASH] and [removed: Drug Administration (“FDA”) clearance in 2023,] [added: Classic Omnipod,] all of which eliminate the need for multiple daily injections using syringes or insulin pens or the use of pump and tubing.

Omnipod DASH features a secure Bluetooth enabled Pod that is controlled by a smartphone-like PDM with [removed: a] color touch screen user interface.

Omnipod 5, which builds on our Omnipod DASH mobile platform, is a tubeless automated insulin delivery system that integrates with a [removed: continuous glucose monitor (“CGM”)] [added: CGM] to manage blood sugar and is fully controlled by a compatible personal smartphone or Omnipod 5 Controller.

The CGM is sold separately by [removed: a] third [removed: party.][added: parties.]

Our [removed: long-term] financial objective is to sustain profitable growth.

To achieve [removed: this goal,] [added: this,] we launched Omnipod 5 in the United States in [removed: August] 2022 and in the United Kingdom and Germany in June and August 2023, respectively.

[removed: We] [added: 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.

[removed: We have completed a] [added: Similar to the] randomized control trial [added: that we completed] in the [removed: U.S.] [added: United States] and France for Omnipod 5 with DexCom’s G6 [removed: continuous glucose monitor (“CGM”)] [added: CGM, the objective is] to [added: provide data to] support our pricing and market access [removed: initiatives.][added: initiatives as we roll out Omnipod 5 with multiple sensors across our international markets.]

[removed: We also] [added: Finally, we] continue to take steps to strengthen our global manufacturing capabilities.

[removed: Finally, we] [added: We also] continue to focus on our product development efforts, including AID [removed: offerings] [added: offerings,] such as choice of smartphone integration and CGM, and enhancing the customer experience through digital product and data capabilities.

[removed: In February 2024,] [added: Similarly, in June 2024] we [removed: began] [added: launched] our [removed: limited] [added: full] market release of Omnipod 5 with [removed: Dexcom’s G7 CGM in the United States and received CE mark approval for the added compatibility of] Libre 2 Plus [removed: with Omnipod 5] for individuals aged two years and older with type 1 [removed: diabetes.][added: diabetes in both the United Kingdom and Netherlands, where we offer sensor of choice (integration with either Abbott’s Libre 2 Plus or Dexcom’s G6 CGM).]

The discussion of our results of operations for [removed: 2021] [added: 2022] has been omitted from this Form 10-K but can be found in Item 7.

Management’s Discussion and Analysis and Results of Operations in our Form 10-K for the fiscal year ended December 31, [removed: 2022] [added: 2023] filed with the Securities and Exchange Commission on February [removed: 24, 2023.][added: 22, 2024.]

Our [removed: Pod is] [added: Pods are] intended to be used continuously for up to three days, after which it [removed: is] [added: may be] replaced with a new disposable Pod.

We recently achieved a milestone of [removed: approximately 425,000] [added: 500,000] estimated active global customers using Omnipod products, including [removed: approximately 250,000] [added: 365,000] global customers using Omnipod 5.

[removed: Our product’s] [added: The] unique patented design [added: 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 [added: pricing model reduces the risk to third-party payors.]

In 2022, we issued two voluntary Medical Device [removed: Corrections (“MDCs”),] [added: Correction (“MDC”) notices,] one [removed: in October] for our Omnipod DASH PDM related to its battery and the other [removed: in November] for our Omnipod 5 Controller related to its charging port and cable.

During [removed: the year ended December 31,] [added: 2022, we initially recorded a net charge of $57.9 million related to these MDCs and, in] 2023, we recorded $11.5 million of income associated with a change in our estimated liability for the MDCs, primarily due to lower distribution costs.

Comparison of the Years Ended December 31, [removed: 2023] [added: 2024] and December 31, [removed: 2022][added: 2023]

| (in millions) | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | | | | | % Change | | | | | | Currency Impact | | | | | | Constant Currency(1) | | |

| Drug Delivery | | | [removed: 36.0] [added: 38.9] | | | | | | [removed: 57.5] [added: 36.0] | | | | | | [removed: (37.4)] [added: 8.1] | | % | | | | — | | % | | | | [removed: (37.4)] [added: 8.1] | | % |

Revenue from the sale of Omnipod products in the U.S. increased [removed: $366.2] [added: $258.3] million, or [removed: 41.4%,] [added: 20.6%,] in [removed: 2023] [added: 2024] to [removed: $1,251.0] [added: $1,509.3] million, compared with [removed: $884.8] [added: $1,251.0] million in [removed: 2022.][added: 2023.]

This increase primarily resulted from higher [removed: volumes] [added: volume through the pharmacy channel] driven by growing our customer [removed: base and, to a lesser extent, growth through the pharmacy channel, where Pods have] [added: base, partially offset by] a [removed: higher average selling price due in part to the fact that we offer the PDM/Controller for no charge, and an increase] [added: decrease] in estimated inventory days-on-hand at [removed: distributors.][added: distributors and lower conversions to Omnipod 5.]

Revenue from the sale of Omnipod products in the U.S. includes [removed: $473.7] [added: $587.8] million of related party revenue in [removed: 2023,] [added: 2024,] compared with [removed: $249.9] [added: $473.7] million in [removed: 2022.][added: 2023.]

The [removed: $223.8] [added: $114.1] million increase primarily resulted from growth through the pharmacy channel.

In [removed: 2024,] [added: 2025,] we expect strong U.S. revenue growth [added: primarily] driven by [removed: continued volume growth of Omnipod 5, continued sales of Omnipod DASH, and] the benefits of our recurring revenue model and [removed: pharmacy channel access.][added: continued volume growth of Omnipod 5.]

Revenue from the sale of Omnipod products in our international markets increased [removed: $47.1] [added: $113.3] million, or [removed: 13.0%,] [added: 27.6%,] in [removed: 2023] [added: 2024] to [removed: $410.1] [added: $523.4] million, compared with [removed: $363.0] [added: $410.1] million in [removed: 2022.][added: 2023.]

In [removed: 2024,] [added: 2025,] we expect higher International [added: Omnipod] revenue due to continued volume growth driven by new customers and conversions to Omnipod 5 [removed: in] [added: primarily due to] the [removed: U.K.] [added: launch of Omnipod 5 in France] and [added: the Netherlands, growth from the earlier launches in] Germany and [removed: to a lesser extent,] the [removed: ongoing adoption] [added: United Kingdom, and the continued roll out] of Omnipod [removed: DASH.][added: 5 in additional markets.]

| Cost of revenue | | | $ | [removed: 537.2] [added: 625.9] | | | | | [removed: 31.7] [added: 30.2] | | % | | | | $ | [removed: 499.7] [added: 537.2] | | | | | [removed: 38.3] [added: 31.7] | | % |

| Research and development expenses | | | $ | [removed: 205.0] [added: 219.6] | | | | | [removed: 12.1] [added: 10.6] | | % | | | | $ | [removed: 180.2] [added: 205.0] | | | | | [removed: 13.8] [added: 12.1] | | % |

| Selling, general and administrative expenses | | | $ | [removed: 734.9] [added: 917.2] | | | | | [removed: 43.3] [added: 44.3] | | % | | | | $ | [removed: 587.8] [added: 734.9] | | | | | [removed: 45.0] [added: 43.3] | | % |

Cost of revenue for [removed: 2023] [added: 2024] increased [removed: $37.5] [added: $88.7] million, or [removed: 7.5%,] [added: 16.5%,] to [removed: $537.2] [added: $625.9] million, compared with [removed: $499.7] [added: $537.2] million in [removed: 2022.][added: 2023.]

Gross margin was [removed: 68.3%] [added: 69.8%] in [removed: 2023,] [added: 2024,] compared with [removed: 61.7%] [added: 68.3%] in [removed: 2022.][added: 2023.]

Research and development expenses [removed: for 2023] increased [removed: $24.8] [added: $14.6] million, or [removed: 13.8%,] [added: 7.1%,] to [removed: $205.0 million,] [added: $219.6 million for 2024,] compared with [removed: $180.2] [added: $205.0] million [removed: in 2022.][added: for 2023.]

Research and development expenses as a percent of revenue [removed: declined] [added: decreased] to [removed: 12.1%] [added: 10.6%] in [removed: 2023,] [added: 2024,] compared with [removed: 13.8%] [added: 12.1%] in [removed: 2022] [added: 2023] primarily due to an increase in sustaining costs following the launch of Omnipod 5 in the United States, which are included in selling, general and administrative expenses.

We expect research and development spending in [removed: 2024] [added: 2025] to increase compared with [removed: 2023] [added: 2024] as we continue to invest in advancing our innovation and clinical pipeline.

Selling, general and administrative expenses [removed: for 2023] increased [removed: $147.1] [added: $182.3] million, or [removed: 25.0%,] [added: 24.8%,] to [removed: $734.9 million,] [added: $917.2 million in 2024,] compared with [removed: $587.8] [added: $734.9] million in [removed: 2022.][added: 2023.]

This increase was primarily attributable to year-over-year headcount [removed: additions, mainly] [added: additions] to support [added: our growth,] international [removed: growth] [added: expansion] and [removed: costs associated with] [added: sustain Omnipod 5, and as a result of] our new [removed: leadership structure that is designed to accelerate innovation and commercialization.][added: organizational structure.]

We expect selling, general and administrative expenses to increase in [removed: 2024] [added: 2025] compared with [removed: 2023] [added: 2024] due to investments in our operating structure, primarily headcount additions, [added: particularly in the areas of customer support, sales and information technology support,] to facilitate continued [removed: growth, including customer support.][added: growth globally.]

We have been phasing-out Classic Omnipod as we launch Omnipod 5.

In June 2024, we launched our full market releases of Omnipod 5 in the Netherlands and France, and most recently, in January 2025, we announced that Omnipod 5 is now available in Italy, Denmark, Finland, Norway, and Sweden.

In August 2024, we received FDA clearance for an expanded indication of Omnipod 5 for people with type 2 diabetes.

Due to the positive results of our Omnipod 5 type 2 pivotal trial and the learnings from our Omnipod GO commercial pilot, we made a strategic decision to drive growth in the type 2 diabetes market with Omnipod 5 and, accordingly, decided not to move forward with the commercialization of Omnipod GO.

During 2024, we completed participant enrollment in our RADIANT study in France, the United Kingdom, and Belgium, which is our Omnipod 5 with Libre 2 randomized controlled trial.

Omnipod 5 integration with Dexcom’s G6 CGM is available in every country where Omnipod 5 is available.

In June 2024, we began our full market release of Omnipod 5 with Dexcom’s G7 CGM in the United States.

We also now offer sensor of choice in the United States, Italy, Denmark, Finland, Norway, and Sweden.

Additionally, in October 2024, our Omnipod 5 app for iPhone compatible with Dexcom’s G6 CGM became fully available in the United States.

In 2024, we began producing product at our newly constructed manufacturing plant in Malaysia.

This plant provides us with increased capacity to satisfy our growing demand, supports our international expansion strategy, and is expected to drive higher gross margins over time.

Following our strategic decision to not move forward with the commercialization of Omnipod GO discussed above, we recorded a charge of $13.5 million related to certain inventory components that we no longer expect to utilize, which is included in our consolidated statement of income for 2024.

| U.S. | | | $ | 1,509.3 | | | | | $ | 1,251.0 | | | | | 20.6 | | % | | | | — | | % | | | | 20.6 | | % |

| International | | | 523.4 | | | | | | 410.1 | | | | | | 27.6 | | % | | | | 0.7 | | % | | | | 26.9 | | % |

| Total Omnipod Products | | | 2,032.7 | | | | | | 1,661.1 | | | | | | 22.4 | | % | | | | 0.2 | | % | | | | 22.2 | | % |

| Total | | | $ | 2,071.6 | | | | | $ | 1,697.1 | | | | | 22.1 | | % | | | | 0.2 | | % | | | | 21.9 | | % |

Total revenue increased $374.5 million, or 22.1%, to $2,071.6 million in 2024, compared with $1,697.1 million in 2023.

Constant currency revenue growth of 21.9% was primarily driven by higher volume largely attributable to our growing customer base and, to a lesser extent, higher price.

Inventory days-on-hand declined to more normal levels following an acceleration of orders by U.S. pharmacy wholesales in advance of the implementation of our new ERP system on January 1, 2024.

We experienced a benefit from conversions to Omnipod 5 in the prior year following the launch of the product in the latter half of 2022 since users generally fill both their Omnipod 5 starter kit and their first month of refills simultaneously.

Conversions to Omnipod 5 declined since the vast majority of U.S. conversions to Omnipod 5 occurred in 2023.

To a lesser extent, the revenue increase was driven by a higher average selling price resulting from our annual wholesale acquisition cost increase implemented during the second quarter of 2024 and growth in the pharmacy channel.

Our recent type 2 indication for Omnipod 5, the launch of Omnipod 5 integrations with both Dexcom’s G7 CGM and Libre 2 Plus, and the launch our Omnipod 5 app for iPhone, are expected to contribute to an increase in our customer base.

Excluding the 0.7% favorable impact of currency exchange, the remaining 26.9% increase in revenue was primarily due to higher volumes from the launches of Omnipod 5 in the United Kingdom and Germany in the prior year, driven by our growing customer base and the favorable impact of conversions to

Omnipod 5.

A higher average selling price for Omnipod 5 compared with Omnipod DASH and Classic Omnipod also contributed to the revenue increase, although to a lesser extent.

Drug Delivery revenue increased $2.9 million, or 8.1%, to $38.9 million in 2024, compared with $36.0 million in 2023.

This increase primarily resulted from an increase in orders from our partner, partially offset by a reimbursement from our partner to cover a portion of our increased production costs in the prior year, which did not repeat in the current year.

Costs and Expenses

| | | | 2024 | | | | | | | | | | | | 2023 | | | | | | | | |

The 1.5 point increase in gross margin was primarily driven by pricing benefits in both the U.S. pharmacy channel and in our international markets, improved manufacturing efficiencies, and procurement savings.

These increases were partially offset by a $13.5 million charge related to certain components utilized in Omnipod GO, which we decided not to commercialize, an $11.5 million accrual reversal during the prior year associated with the voluntary MDC notices we issued in 2022, which did not recur in the current year, and higher costs due to inflation.

We expect gross margin to further increase to approximately 70.5% in 2025 primarily due to improved manufacturing efficiencies.

To a lesser extent, the increase was due to higher legal fees to defend our intellectual property and support our business growth; an increase in advertising expense; higher costs associated with the continued commercial rollout of Omnipod 5 in international markets; and increases in travel and expenses resulting from headcount additions.

Interest expense increased $6.5 million to $42.7 million in 2024, compared with $36.2 million in 2023 primarily due to fees paid to amend our Term Loan.

Interest income increased $10.9 million to $39.5 million in 2024, compared with $28.6 million in 2023 primarily driven by increased average cash balances and higher interest rates.

Other expense, net of $5.5 million for 2024 consists primarily of $3.8 million of loss related to fair value adjustments associated with a strategic debt investment.

Our effective tax rate was a benefit of 39.3% for 2024, compared with a provision of 3.9% for 2023.

The decrease in our effective tax rate was primarily due to a $182.5 million non-cash tax benefit from the release of the majority of our valuation allowance against deferred tax assets discussed in Note 22 to our consolidated financial statements and a $8.3 million tax benefit from a research and development tax credit recovery project for the years 2017 through 2022.

These tax benefits were partially offset by a $8.2 million decrease in tax benefits from employee stock-based compensation.

Omnipod GO, for which we are currently conducting a pilot program in the United States, is our basal-only Pod for individuals with type 2 diabetes age 18 and older who require insulin.

Subsequent to the launch of Omnipod 5, we began to phase-out our Classic Omnipod in the U.S. in 2023, since the vast majority of our U.S. customer base is no longer using this product.

We plan to launch Omnipod 5 in more European markets in 2024 starting with the Netherlands.

Additionally, in December 2023, we completed enrollment for our pivotal trial for Omnipod 5 with the goal of expanding Omnipod 5’s indication to type 2 users.

We expect to complete the trial and submit to the FDA for an expanded indication by the end of 2024.

We recently completed construction of a new manufacturing plant in Malaysia to support our international expansion strategy, further ensure product supply, and drive higher gross margins over time.

We expect to begin production at this new manufacturing facility in 2024.

We expect to launch a limited market release of Omnipod 5 with Libre 2 Plus in the U.K. and the Netherlands in 2024.

Additionally, we received FDA clearance for the Omnipod 5 App for iPhone in the fourth quarter of 2023 and plan to launch a limited market release in the U.S. in 2024.

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pricing model reduces the risk to third-party payors.

During 2022, we initially recorded a net charge of $57.9 million related to these MDCs.

We continue to experience challenges stemming from the global supply chain disruption; however, while there is no guarantee of future performance, to date we have been able to successfully mitigate this disruption and ensure uninterrupted supply to our customers by increasing our inventory levels and taking other measures.

While our mitigation efforts and inflation have and are expected to continue to negatively impact gross margins and net income in 2024, we intend to continue to work to improve productivity to help offset these costs.

| U.S. | | | $ | 1,251.0 | | | | | $ | 884.8 | | | | | 41.4 | | % | | | | — | | % | | | | 41.4 | | % |

| International | | | 410.1 | | | | | | 363.0 | | | | | | 13.0 | | % | | | | 1.6 | | % | | | | 11.4 | | % |

| Total Omnipod Products | | | 1,661.1 | | | | | | 1,247.8 | | | | | | 33.1 | | % | | | | 0.4 | | % | | | | 32.7 | | % |

| Total | | | $ | 1,697.1 | | | | | $ | 1,305.3 | | | | | 30.0 | | % | | | | 0.4 | | % | | | | 29.6 | | % |

Total revenue for 2023 increased $391.8 million, or 30.0%, to $1,697.1 million, compared with $1,305.3 million in 2022.

Constant currency revenue growth of 29.6% was primarily driven by higher volume and, to a lesser extent, favorable sales channel mix, partially offset by decreased drug delivery revenue.

We expect these increases to be partially offset by lower conversions from Classic Omnipod and Omnipod DASH to Omnipod 5 in the first half of the year compared to 2023 since the vast majority of conversions to Omnipod 5 occurred in 2023.

Excluding the 1.6% favorable impact of currency exchange, the remaining 11.4% increase in revenue was primarily due to higher volumes as we continue to expand awareness and access to Omnipod DASH and, to a lesser extent, the timing of revenue recognition related to deferrals associated with our Omnipod DASH MDC and a technology upgrade program, and product mix from the launch of Omnipod 5 in the United Kingdom.

These increases were partially offset by a decrease in estimated days-on-hand at distributors and higher attrition in the countries where we have not yet launched Omnipod 5 as we continue to be impacted by competition from AID systems.

We expect these increases to be partially offset by competition from AID systems.

Drug Delivery revenue for 2023 decreased $21.5 million, or 37.4%, to $36.0 million, compared with $57.5 million in 2022.

This decrease primarily resulted from a lower forecast from our partner, partially offset by a higher selling price.

In 2024, we expect Drug Delivery revenue to decline $18 million to $22 million due to a lower forecast from our partner.

Operating Expenses

| | | | 2023 | | | | | | | | | | | | 2022 | | | | | | | | |

The 6.6 point increase in gross margin was primarily driven by the $57.9 million net charge associated with the voluntary MDC notices issued in 2022, which did not repeat in the current period, and an $11.5 million revision to the voluntary MDC liability in 2023, due to lower than expected distribution costs.

The increase was also driven by higher average selling prices primarily due to growth in the pharmacy channel and improved manufacturing efficiencies.

These increases were partially offset by higher production costs associated with Omnipod 5 and U.S. manufacturing as it continues to become a larger portion of total production, and to a lesser extent, continued inflation.

We expect gross margin for 2024 to be in the range of 68% to 69%.

We anticipate gross margin to be relatively level due to higher average selling prices primarily due to growth in the pharmacy channel and improved manufacturing efficiencies, partially offset by $11.5 million of income associated with a reduction to our MDC liability in 2023, which will not recur, and higher costs associated with our new product launches.

This increase was primarily due to year-over-year headcount additions to support our continued investment in the development of Omnipod products and third-party costs to support clinical trials.

In addition, we had higher direct-to-consumer advertising spend and third-party customer service costs to support Omnipod 5 adoption, and an increase in software license fees driven by investments in new systems due to our growing business and increased headcount.

To a lesser extent, the increase was due to higher amortization of cloud computing implementation costs and higher third-party training costs.

These increases were partially offset by $27.3 million of legal costs incurred in the prior year related to the settlement of a patent infringement lawsuit, associated legal fees, and an estimated liability to settle a contract dispute.

Interest expense of $36.2 million in 2023 was level with interest expense of $36.0 million in 2022.

Interest income for 2023 increased $19.3 million to $28.6 million, compared with $9.3 million in 2022.

At December 31, [removed: 2023,] [added: 2024,] no amounts were outstanding under our Revolving Credit Facility.

In May 2021, we entered into two interest rate swap agreements to effectively convert $480.0 million of our term loan borrowings from a variable rate to a fixed [removed: rate.][added: rate through April 2025.]

A 100 basis point increase or decrease in interest rates as of December 31, [removed: 2023] [added: 2024] would [removed: decrease or increase] [added: have an insignificant impact on] our annual [removed: earnings, respectively, by approximately $0.1 million.][added: earnings.]

As of December 31, [removed: 2023,] [added: 2024,] we had outstanding debt related to our [removed: convertible senior notes] [added: Convertible Senior Notes] recorded on our consolidated balance sheet of [removed: $791.8] [added: $794.9] million, net of unamortized discount and issuance costs totaling [removed: $8.2] [added: $5.1] million.

The fair value of the [removed: convertible senior notes,] [added: Convertible Senior Notes,] which was [removed: $765.6] [added: $1,018.8] million as of December 31, [removed: 2023,] [added: 2024,] is also impacted by changes in our stock price.

In order to reduce potential equity dilution, in connection with the issuance of the [removed: $800.0 million aggregate principal amount of 0.375%] [added: Convertible Senior] Notes, we [removed: entered into] [added: purchased] Capped Calls.

We expect the Capped Calls to reduce the potential dilution to our common stock (or, in the event the conversion is settled in cash, to provide a source of cash to settle a portion of our cash payment obligation) [removed: in the event that] [added: if] at the time of conversion our stock price exceeds the conversion price under the [removed: 0.375%] [added: Convertible Senior] Notes.

The Capped Calls have an [removed: initial strike] [added: upper protection] price of $335.90 per share and cover 3.5 million shares of common stock.

Foreign currency risk arises from our investments in subsidiaries owned and operated in [removed: non-U.S. countries.][added: countries other than the United States.]

Such risk is also a result of transactions with customers in [removed: countries outside the United States.][added: those countries.]

Approximately [removed: 24%] [added: 25%] of our revenue was denominated in foreign currencies for the year ended December 31, [removed: 2023.][added: 2024.]

Fluctuations in the rate of exchange between the United States dollar and foreign currencies, primarily the Euro, British pound and [removed: Malaysia] [added: Malaysian] ringgit, could [removed: adversely] affect our financial results, including our revenues, revenue growth rates, gross margins, [removed: income] [added: operating income,] and [removed: losses] [added: net income] as well as assets and liabilities.

[removed: We] [added: At December 31, 2024, we] have intercompany receivables and payables from our foreign subsidiaries that are denominated in [removed: foreign] [added: their functional] currencies, principally the [removed: Euro, the British pound, Mexican peso, Malaysian ringgit and the Canadian dollar.][added: Chinese yuan renminbi.]

[added: Net realized and unrealized gains (losses) from] foreign currency transactions are included in other [removed: income (expense),] [added: (expense) income,] net in the consolidated [removed: statement] [added: statements] of [removed: operations] [added: income] and amounted to a loss of [removed: $0.4] [added: $2.3] million for the year ended December 31, [removed: 2023.][added: 2024.]

Net realized and unrealized gains (losses) from

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Insulet Corporation (“we” or the “Company”) is primarily engaged in the development, [removed: manufacture] [added: manufacture,] and sale of its proprietary continuous insulin delivery systems for people with insulin-dependent diabetes.

The Omnipod platform includes: the Omnipod® 5 Automated Insulin Delivery System (“Omnipod 5”), the Omnipod DASH® Insulin Management System (“Omnipod DASH”), [added: and] the Omnipod Insulin Management System (“Classic [removed: Omnipod”) and our latest innovation, Omnipod GOTM, which received U.S. Food and Drug Administration (“FDA”) clearance in 2023.][added: Omnipod”).]

We estimate that approximately [removed: five] [added: 5] million people have type 1 diabetes in the countries we currently serve.

People with type 2 diabetes who take insulin either require intensive insulin therapy (typically multiple injections of insulin per day) or basal [added: (long-acting)] insulin (typically a single injection daily or weekly).

We estimate that approximately [removed: six] [added: 6] million people have insulin-intensive type 2 diabetes in the countries we currently serve and another [removed: three] [added: 3] million people with type 2 diabetes [removed: require only long-acting insulin] in the United [removed: States.][added: States require only long-acting insulin.]

We estimate that approximately 40% of the type 1 diabetes population in the United States and [removed: even less] [added: 20%] of the international type 1 diabetes population use insulin pump therapy.

An even smaller portion of the U.S. and international insulin-intensive type 2 diabetes population [added: and the U.S. basal only insulin type 2 population] use insulin pump therapy.

In addition to basal insulin, people with insulin-dependent diabetes require supplemental insulin, known as bolus insulin, [added: to compensate for carbohydrates ingested during meals or snacks or for a high blood glucose level caused by other physiological reasons.]

We believe that these advantages, along with technological advancements, including the use of continuous glucose monitoring technology and automated insulin device (“AID”) algorithms, and increased awareness of insulin pump [removed: therapy] [added: therapy,] will continue to generate demand for insulin pump devices.

| [removed: ] [added: ] | | | [removed: ] [added: ] | | | [removed: ] [added: ] | | |

| Omnipod 5 | | | Omnipod DASH | | | [removed: Omnipod GO] | | |

In [removed: September] 2022, we received [added: U.S. Food and Drug Administration (“FDA”) clearance and] CE Mark approval [removed: for Omnipod 5] under the European Union Medical Device Regulation (“MDR”) [removed: and in 2023, we launched] [added: for] Omnipod [removed: 5 in the United Kingdom and Germany.][added: 5, which builds on our Omnipod DASH platform.]

[removed: The Pod is controllable by an Insulet-provided] handheld device [removed: (Controller)] or a user-downloaded Android [added: app or, in the US, the iOS] app, [removed: which allows for] [added: with] full [removed: compatible] smartphone [removed: control.][added: compatibility.]

The Omnipod 5 Controller and the [removed: Omnipod 5] Android and iOS apps use cloud-based technology to [removed: wirelessly] upload data [removed: using] [added: wirelessly via] a built-in SIM card [removed: for cellular connectivity] or [removed: from a] secure [removed: Wi-Fi][added: Wi-Fi.]

Accordingly, we are [removed: phasing-out] [added: phasing out] our Classic Omnipod [removed: product in the U.S. and no longer guarantee the availability of its supplies.][added: product.]

With certifications from the Diabetes Technology Society’s “Standard for Wireless Diabetes Device Security” cybersecurity and assurance standard and program as well as from the International Organization for Standardization [removed: (“IOS”),] [added: (“ISO”),] Insulet is globally recognized for incorporating the highest standards for cybersecurity, information [removed: security] [added: security,] and safety, including secure data transfer between the Pod and PDM, as well as secure cloud storage.

[added: Our Omnipod platform’s unique patented] design allows us to provide Pod therapy at a relatively low or no up-front investment, which reduces the risk to third-party payors in the [removed: U.S.][added: United States.]

In our international [removed: locations] [added: locations,] we sell either directly to consumers or through a distributor/intermediary.

In all countries where we [removed: operate] [added: operate,] either Insulet or our partners establish appropriate reimbursement contracts with healthcare systems in those countries and provinces.

| Australia | | | Cyprus | | | Greece | | | [removed: Netherlands] [added: Netherlands*] | | | Switzerland | | |

| Austria | | | [removed: Denmark] [added: Denmark*] | | | Iceland | | | [removed: Norway] [added: Norway*] | | | Turkey | | |

| Belgium | | | [removed: Finland] [added: Finland*] | | | Israel | | | Qatar | | | United Arab Emirates | | |

| Canada | | | [removed: France] [added: France*] | | | [removed: Italy] [added: Italy*] | | | Saudi Arabia | | | United [removed: Kingdom] [added: Kingdom*] | | |

| Croatia | | | [removed: Germany] [added: Germany*] | | | Kuwait | | | [removed: Sweden] [added: Sweden*] | | | United [removed: States] [added: States*] | | |

[removed: We] [added: In addition, we] sell Omnipod products [removed: directly to consumers,] through distribution partners and [removed: in the U.S., also through the pharmacy channel.][added: directly to consumers.]

For the year ended December 31, [removed: 2023, 90%] [added: 2024, 88%] of Omnipod product sales globally were through intermediaries.

| | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | |

| Distributor A | | | 28% | | | | | | [removed: 19%] [added: 28%] | | | | | | [removed: *] [added: 19%] | | |

| Distributor B | | | [removed: 24%] [added: 26%] | | | | | | [removed: 16%] [added: 24%] | | | | | | [removed: *] [added: 16%] | | |

| Distributor C | | | [removed: 19%] [added: 21%] | | | | | | [removed: 17%] [added: 19%] | | | | | | [removed: 12%] [added: 17%] | | |

We have a comprehensive sales and marketing approach, which communicates the benefits of the Omnipod platform to users, [removed: physicians] [added: physicians,] and providers.

We created an online training program for Omnipod customers transitioning to Omnipod [removed: DASH] [added: 5] or Omnipod [removed: 5.][added: DASH.]

Our distributors [removed: and intermediaries] have also implemented virtual training programs.

We seek to provide our customers with high quality customer support, from product ordering to insurance investigation, order [removed: fulfillment] [added: fulfillment,] and ongoing support.

Our customer support systems are integrated with our sales, [removed: reimbursement] [added: reimbursement,] and billing processes, allowing us to provide customers with reliable support by telephone and through our website.

The diabetes medical device market is highly competitive, subject to rapid [removed: change] [added: change,] and significantly affected by new product introductions.

Because most new Omnipod users come from MDI therapy, which currently is the most prevalent method of insulin delivery, we believe that we primarily [added: compete with companies that provide products and supplies for MDI therapy.]

We also compete with companies in the insulin pump market, which today consists of tubed pump companies, [removed: including] [added: primarily] Medtronic MiniMed, a division of Medtronic public limited company [removed: (“Medtronic”),] [added: (“Medtronic”)] and Tandem Diabetes Care Inc. (“Tandem”).

In addition to the established insulin pump competitors, several companies are [removed: working to develop and market new insulin pumps and smart pens.]

- simplicity of user interaction with our [removed: systems;][added: systems to minimize the burden of diabetes;]

It is diagnosed throughout the age spectrum, with over half of newly diagnosed cases occurring in adulthood.

Omnipod 5 is now available in 10 countries.

Additionally, in August 2024, we received FDA clearance for an expanded indication of Omnipod 5 for people with type 2 diabetes (ages 18 years and older) in the United States.

The Pod can be controlled by an Insulet-provided

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 as depicted under *Markets and Distribution Methods*.

In the United States, we sell our products primarily through wholesalers and, to a lesser extent to healthcare organizations, pharmacies, and consumers.

In some cases, we seek reimbursement from government administrative payors and/or health insurance companies.

* Represents country in which Omnipod 5 is available

We sell Omnipod products to wholesalers that supply the pharmacy channel in the United States.

working to develop and market new insulin pumps and smart pens.

Advances in innovation in 2024 include the following:

- received FDA clearance for an expanded indication of Omnipod 5 for type 2 diabetes for people aged 18 years and older in the United States;

- launched iOS app with Dexcom’s G6 CGM in the United States;

- launched Omnipod 5 integration with Dexcom’s G6 CGM in France;

- launched Omnipod 5 integration with Libre 2 Plus in the United States, United Kingdom.

and Netherlands.

The study included testing the system with both type 1 and type 2 users.

The California laws have served as a model for similar laws in other states like the Consumer Data Protection Act in Virginia and the Colorado Privacy Act.

Because of the breadth of these

*U.S. Foreign Corrupt Practices Act (*“*FCPA*”*).* We are subject to FCPA in the United States.

*Artificial Intelligence (*“*AI*”*).* Governments around the world have begun to regulate AI, including Generative AI.

The EU AI Act was enacted in August 2024, with provisions taking effect over time, through August 2026.

U.S. states are also starting to legislate in this area, as are other countries.

Federal regulation in the United States is in flux at this time, given the recent change in administrations.

To the extent we develop or deploy AI systems in our business operations or in our products, we will be subject to AI regulations governing AI systems.

We are engaged in regular reviews of development and licensing of software used in the business for compliance with relevant AI regulations.

Guidance from EU regulators is starting to be published and we will continue to track developments in this area and adjust operations accordingly.

In addition, we are subject to numerous federal, state, foreign, and local laws relating to safe working conditions, manufacturing practices, and environmental protection.

We may be required to incur significant costs to comply with these laws and regulations in the future and complying with these laws may result in a material adverse effect on our business, financial condition, and results of operations.

Increasingly, regulators, customers, investors, employees, and other stakeholders are focusing on environmental, social and governance matters and related disclosures.

These changing rules, regulations, and stakeholder expectations have resulted in, and are likely to continue to result in, increased general and administrative expenses and increased management time and attention spent meeting such regulations and expectations and complying with disclosure requirements.

For example, collecting, measuring, and reporting environmental data is subject to evolving reporting standards, including California’s climate disclosure requirements, and similar regulations established by other international regulatory bodies, such as the Corporate Sustainability Reporting Directive in the European Union.

In addition, a number of our customers who are payors or distributors have adopted, or may adopt, procurement policies that include environmental provisions that their suppliers or manufacturers must comply with.

If we do not adapt to or comply with new regulations, or fail to meet evolving investor, industry, or stakeholder expectations and concerns regarding environmental issues, investors may reconsider their investment in us, and customers and suppliers may choose to limit their business with us, which could have a material adverse effect on our business, operations, or reputation.

Certain devices that comply with the requirements of the MDD can be commercially distributed until December 2027 if certain requirements are met.

In 2024, we defined and shared our Ways of Working, the key behaviors that we believe are most important to our success and to creating an exceptional employee experience.

Additionally, in 2024, we launched our Insulet for Good program, which enables employees globally to engage in volunteerism and corporate philanthropy in ways aligned with our corporate strategic priorities.

These ERGs support the attraction, engagement, development, and retention of our people.

Our people are core to our success and the achievement of our business strategy.

We are therefore committed to fostering an environment in which our employees continuously learn and develop the skills and capabilities needed for their success by offering both leadership and professional skills development programs.

It is frequently diagnosed during childhood or adolescence.

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to compensate for carbohydrates ingested during meals or snacks or for a high blood glucose level caused by other physiological reasons.

Omnipod 5, which builds on our Omnipod DASH platform, described below, was cleared by the FDA in January 2022.

Our limited market release of Omnipod 5 in the United States commenced the following month, and in August 2022 we launched our U.S. full market release.

In addition, in October 2023, we received FDA clearance for our Omnipod 5 App for iPhone, which allows for control using a compatible iOS smartphone.

We expect to launch the iOS app in 2024.

connection if established.

The Pod currently integrates with Dexcom, Inc.’s G6 CGM and we recently launched a limited market release with Dexcom’s G7 CGM.

Additionally, we plan to launch Omnipod 5 with Abbott Diabetes Care, Inc.’s FreeStyle Libre 2 Plus sensor (“Libre 2 Plus”) in certain international markets in 2024.

Omnipod GO

Omnipod GO is a standalone, wearable, insulin delivery system that provides a fixed rate of continuous rapid-acting insulin for 72 hours.

Omnipod GO has been cleared by the FDA for use by people with type 2 diabetes age 18 and older who would typically take daily injections of long-lasting insulin.

The newest addition to the Omnipod brand features a tubeless and waterproof Pod (with an IP28 rating for up to 25 feet for 60 minutes) which is offered in seven different pre-programmed daily rates, ranging from 10 to 40 units per day, and operates without the need for a handheld device to control the Pod.

Omnipod GO has been cleared for use with the following U-100 insulins: NovoLog®, Fiasp®, Humalog®, Admelog®, and Lyumjev®.

The product was developed to serve people with type 2 diabetes earlier in their treatment journey by starting them on Pod therapy for their insulin delivery, rather than daily injections.

As a patient progresses to requiring additional insulin, including basal and bolus, the transition from Omnipod GO to another Omnipod product will be a natural progression.

We developed Omnipod GO with convenience in mind for both the primary care physician and the user, including with respect to prescribing, getting started, training and using the product.

We are currently conducting a pilot program for Omnipod GO in the United States.

In the United States, entities to whom our products are sold (including wholesalers, private healthcare organizations, healthcare facilities, mail order pharmacies, independent retailers, and consumers), and the Company in some cases, seek reimbursement from health insurance companies and/or government administrative payors.

Our Omnipod platform’s unique patented

* Represents less than 10% of revenue for the period.

compete with companies that provide products and supplies for MDI therapy.

Medtronic historically has held the majority share of the tubed insulin pump market.

In October 2023, we received FDA clearance for an iOS app that will enable control of Omnipod 5 Pods using an iPhone and plan to launch a limited market release in the U.S. in 2024.

In December 2023, we completed enrollment in our pivotal trial for Omnipod 5 with the goal of expanding its indication to individuals with type 2 diabetes.

We expect to complete the trial and submit our 510(k) application to the FDA by the end of 2024.

Further, in April 2023, we received FDA clearance for Omnipod GO, a basal-only Pod for individuals with type 2 diabetes.

In 2019, we began producing Pods at our highly automated manufacturing facility in Acton, Massachusetts to increase supply redundancy and add capacity closer to our North American customer base to support the growth of our business.

We expect to begin production at this facility in 2024.

In the case of sole sourced parts, we manage risk

for some of our future products.

In addition, several states require that durable medical equipment (“DME”) providers be licensed in order to sell products in that state.

Certain of these states require, among other things, that DME providers maintain an in-state location.

know is likely to influence the beneficiary’s selection of a particular supplier of Medicare or Medicaid payable items or services.

The California Privacy Rights Act (“CPRA”) amends and expands the CCPA with respect to personal data collected beginning in January 2022.

CPRA enforcement is scheduled to begin in March of 2024.

Virginia and Colorado have enacted similar laws.

The Consumer Data Protection Act in Virginia and the Colorado Privacy Act both became effective in 2023.

respect to user training.

The information required by this Item is provided under “Legal Proceedings” in Note [removed: 19] [added: 18] to the consolidated financial statements included in Item 8 of this Form 10-K and is incorporated herein by reference.

| | | | For the fiscal year ended | | | December 31, [removed: 2023] [added: 2024] | | |

The aggregate market value of the common stock held by non-affiliates of the registrant computed by reference to the last reported sale price of the Common Stock as reported on The NASDAQ Global Market on June 30, [removed: 2023] [added: 2024] was approximately [removed: $20.1] [added: $14.1] billion.

The number of shares of common stock outstanding as of February [removed: 15, 2024] [added: 13, 2025] was [removed: 69,925,730.][added: 70,226,104.]

The registrant intends to file a proxy statement pursuant to Regulation 14A within 120 days of the end of the fiscal year ended December 31, [removed: 2023.][added: 2024.]

| Item 1 | | | [removed: [Business](#i5c5eb5e0e38c49dcae99416b1fdf5f72_13)] [added: [Business](#i777829bdc5b24aee9c434bde8dd545a5_13)] | | | [removed: [3](#i5c5eb5e0e38c49dcae99416b1fdf5f72_13)] [added: [3](#i777829bdc5b24aee9c434bde8dd545a5_13)] | | |

| Item 1A | | | [Risk [removed: Factors](#i5c5eb5e0e38c49dcae99416b1fdf5f72_16)] [added: Factors](#i777829bdc5b24aee9c434bde8dd545a5_16)] | | | [removed: [15](#i5c5eb5e0e38c49dcae99416b1fdf5f72_16)] [added: [15](#i777829bdc5b24aee9c434bde8dd545a5_16)] | | |

| Item 1B | | | [Unresolved Staff [removed: Comments](#i5c5eb5e0e38c49dcae99416b1fdf5f72_19)] [added: Comments](#i777829bdc5b24aee9c434bde8dd545a5_19)] | | | [removed: [28](#i5c5eb5e0e38c49dcae99416b1fdf5f72_19)] [added: [27](#i777829bdc5b24aee9c434bde8dd545a5_19)] | | |

| Item 1C | | | [removed: [Cybersecurity](#i5c5eb5e0e38c49dcae99416b1fdf5f72_1674)] [added: [Cybersecurity](#i777829bdc5b24aee9c434bde8dd545a5_22)] | | | [removed: [28](#i5c5eb5e0e38c49dcae99416b1fdf5f72_1674)] [added: [28](#i777829bdc5b24aee9c434bde8dd545a5_22)] | | |

| Item 2 | | | [removed: [Properties](#i5c5eb5e0e38c49dcae99416b1fdf5f72_22)] [added: [Properties](#i777829bdc5b24aee9c434bde8dd545a5_25)] | | | [removed: [29](#i5c5eb5e0e38c49dcae99416b1fdf5f72_22)] [added: [29](#i777829bdc5b24aee9c434bde8dd545a5_25)] | | |

| Item 3 | | | [Legal [removed: Proceedings](#i5c5eb5e0e38c49dcae99416b1fdf5f72_25)] [added: Proceedings](#i777829bdc5b24aee9c434bde8dd545a5_28)] | | | [removed: [29](#i5c5eb5e0e38c49dcae99416b1fdf5f72_25)] [added: [29](#i777829bdc5b24aee9c434bde8dd545a5_28)] | | |

| Item 4 | | | [Mine Safety [removed: Disclosures](#i5c5eb5e0e38c49dcae99416b1fdf5f72_28)] [added: Disclosures](#i777829bdc5b24aee9c434bde8dd545a5_31)] | | | [removed: [29](#i5c5eb5e0e38c49dcae99416b1fdf5f72_28)] [added: [29](#i777829bdc5b24aee9c434bde8dd545a5_31)] | | |

| Item 5 | | | [Market for [removed: Registrant](#i5c5eb5e0e38c49dcae99416b1fdf5f72_34)’[s] [added: Registrant](#i777829bdc5b24aee9c434bde8dd545a5_37)’[s] Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#i5c5eb5e0e38c49dcae99416b1fdf5f72_34)] [added: Securities](#i777829bdc5b24aee9c434bde8dd545a5_37)] | | | [removed: [30](#i5c5eb5e0e38c49dcae99416b1fdf5f72_34)] [added: [30](#i777829bdc5b24aee9c434bde8dd545a5_37)] | | |

| Item 6 | | | [removed: [Reserved](#i5c5eb5e0e38c49dcae99416b1fdf5f72_37)] [added: [Reserved](#i777829bdc5b24aee9c434bde8dd545a5_40)] | | | [removed: [31](#i5c5eb5e0e38c49dcae99416b1fdf5f72_37)] [added: [31](#i777829bdc5b24aee9c434bde8dd545a5_40)] | | |

| Item 7 | | | [removed: [Management](#i5c5eb5e0e38c49dcae99416b1fdf5f72_40)’[s] [added: [Management](#i777829bdc5b24aee9c434bde8dd545a5_43)’[s] Discussion and Analysis of Financial Condition and Results of [removed: Operations](#i5c5eb5e0e38c49dcae99416b1fdf5f72_40)] [added: Operations](#i777829bdc5b24aee9c434bde8dd545a5_43)] | | | [removed: [32](#i5c5eb5e0e38c49dcae99416b1fdf5f72_40)] [added: [32](#i777829bdc5b24aee9c434bde8dd545a5_43)] | | |

| Item 7A | | | [Quantitative and Qualitative Disclosures About Market [removed: Risk](#i5c5eb5e0e38c49dcae99416b1fdf5f72_61)] [added: Risk](#i777829bdc5b24aee9c434bde8dd545a5_67)] | | | [removed: [41](#i5c5eb5e0e38c49dcae99416b1fdf5f72_61)] [added: [40](#i777829bdc5b24aee9c434bde8dd545a5_67)] | | |

| Item 8 | | | [Financial Statements and Supplementary [removed: Data](#i5c5eb5e0e38c49dcae99416b1fdf5f72_64)] [added: Data](#i777829bdc5b24aee9c434bde8dd545a5_70)] | | | [removed: [42](#i5c5eb5e0e38c49dcae99416b1fdf5f72_64)] [added: [41](#i777829bdc5b24aee9c434bde8dd545a5_70)] | | |

| Item 9 | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#i5c5eb5e0e38c49dcae99416b1fdf5f72_169)] [added: Disclosure](#i777829bdc5b24aee9c434bde8dd545a5_178)] | | | [removed: [77](#i5c5eb5e0e38c49dcae99416b1fdf5f72_169)] [added: [76](#i777829bdc5b24aee9c434bde8dd545a5_178)] | | |

| Item 9A | | | [Controls and [removed: Procedures](#i5c5eb5e0e38c49dcae99416b1fdf5f72_172)] [added: Procedures](#i777829bdc5b24aee9c434bde8dd545a5_181)] | | | [removed: [77](#i5c5eb5e0e38c49dcae99416b1fdf5f72_172)] [added: [76](#i777829bdc5b24aee9c434bde8dd545a5_181)] | | |

| Item 9B | | | [Other [removed: Information](#i5c5eb5e0e38c49dcae99416b1fdf5f72_175)] [added: Information](#i777829bdc5b24aee9c434bde8dd545a5_184)] | | | [removed: [81](#i5c5eb5e0e38c49dcae99416b1fdf5f72_175)] [added: [77](#i777829bdc5b24aee9c434bde8dd545a5_184)] | | |

| Item 10 | | | [Directors, Executive Officers and Corporate [removed: Governance](#i5c5eb5e0e38c49dcae99416b1fdf5f72_181)] [added: Governance](#i777829bdc5b24aee9c434bde8dd545a5_193)] | | | [removed: [81](#i5c5eb5e0e38c49dcae99416b1fdf5f72_181)] [added: [77](#i777829bdc5b24aee9c434bde8dd545a5_193)] | | |

| Item 11 | | | [Executive [removed: Compensation](#i5c5eb5e0e38c49dcae99416b1fdf5f72_184)] [added: Compensation](#i777829bdc5b24aee9c434bde8dd545a5_196)] | | | [removed: [81](#i5c5eb5e0e38c49dcae99416b1fdf5f72_184)] [added: [77](#i777829bdc5b24aee9c434bde8dd545a5_196)] | | |

| Item 12 | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#i5c5eb5e0e38c49dcae99416b1fdf5f72_187)] [added: Matters](#i777829bdc5b24aee9c434bde8dd545a5_199)] | | | [removed: [81](#i5c5eb5e0e38c49dcae99416b1fdf5f72_187)] [added: [77](#i777829bdc5b24aee9c434bde8dd545a5_199)] | | |

| Item 13 | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#i5c5eb5e0e38c49dcae99416b1fdf5f72_190)] [added: Independence](#i777829bdc5b24aee9c434bde8dd545a5_202)] | | | [removed: [81](#i5c5eb5e0e38c49dcae99416b1fdf5f72_190)] [added: [77](#i777829bdc5b24aee9c434bde8dd545a5_202)] | | |

| Item 14 | | | [Principal Accounting Fees and [removed: Services](#i5c5eb5e0e38c49dcae99416b1fdf5f72_193)] [added: Services](#i777829bdc5b24aee9c434bde8dd545a5_205)] | | | [removed: [81](#i5c5eb5e0e38c49dcae99416b1fdf5f72_193)] [added: [77](#i777829bdc5b24aee9c434bde8dd545a5_205)] | | |

| Item 15 | | | [Exhibits, Financial Statement [removed: Schedules](#i5c5eb5e0e38c49dcae99416b1fdf5f72_199)] [added: Schedules](#i777829bdc5b24aee9c434bde8dd545a5_211)] | | | [removed: [82](#i5c5eb5e0e38c49dcae99416b1fdf5f72_199)] [added: [78](#i777829bdc5b24aee9c434bde8dd545a5_211)] | | |

| Item 16 | | | [Form 10-K [removed: Summary](#i5c5eb5e0e38c49dcae99416b1fdf5f72_202)] [added: Summary](#i777829bdc5b24aee9c434bde8dd545a5_214)] | | | [removed: [86](#i5c5eb5e0e38c49dcae99416b1fdf5f72_202)] [added: [82](#i777829bdc5b24aee9c434bde8dd545a5_214)] | | |

| [PART I](#i777829bdc5b24aee9c434bde8dd545a5_10) | | | | | | | | |

| [PART II](#i777829bdc5b24aee9c434bde8dd545a5_190) | | | | | | | | |

| [PART II](#i777829bdc5b24aee9c434bde8dd545a5_190)I | | | | | | | | |

| [PART I](#i777829bdc5b24aee9c434bde8dd545a5_190)V | | | | | | | | |

| | | | [SIGNATURES](#i777829bdc5b24aee9c434bde8dd545a5_217) | | | [83](#i777829bdc5b24aee9c434bde8dd545a5_217) | | |

| [PART I](#i5c5eb5e0e38c49dcae99416b1fdf5f72_10) | | | | | | | | |

| [PART II](#i5c5eb5e0e38c49dcae99416b1fdf5f72_178) | | | | | | | | |

| [PART II](#i5c5eb5e0e38c49dcae99416b1fdf5f72_178)I | | | | | | | | |

| [PART I](#i5c5eb5e0e38c49dcae99416b1fdf5f72_178)V | | | | | | | | |

| | | | [SIGNATURES](#i5c5eb5e0e38c49dcae99416b1fdf5f72_205) | | | [87](#i5c5eb5e0e38c49dcae99416b1fdf5f72_205) | | |

[Table](#i5c5eb5e0e38c49dcae99416b1fdf5f72_7) [of Contents](#i5c5eb5e0e38c49dcae99416b1fdf5f72_7)

We manage cyber risk on a daily basis, as we face a multitude of threats ranging from [removed: ransomware and] [added: ransomware,] phishing attacks, business email compromise, and a wide array of other cyber-criminal tactics aimed at impacting our operations and compromising our sensitive information.

Our customers, suppliers, [removed: subcontractors] [added: subcontractors,] and partners face similar cybersecurity threats, and a cybersecurity incident impacting us or any of these entities could materially adversely affect our operations, performance and results of operations.

Accordingly, we have invested in resources (people, [removed: process,] [added: processes,] and technology) aimed at identifying, assessing, and responding to cyber threats.

While the Board reviews the Company’s cybersecurity program annually, the Nominating, Governance, and Risk Committee [added: (“NGR Committee”)] of the Board has primary responsibility for cybersecurity as part of its risk oversight mandate.

The [removed: Nominating, Governance, and Risk] [added: NGR] Committee is [removed: scheduled to have regular updates] [added: updated] on cybersecurity matters from our Chief Information Security Officer (“CISO”) and members of the CISO’s team at least [removed: two times per year.][added: twice annually.]

The CISO [removed: will discuss] [added: discusses] management’s actions to identify and detect threats and [removed: review] [added: reviews] the structure of and enhancements to the Company’s defenses as well as management’s progress on its cybersecurity strategic roadmap.

The [removed: Nominating, Governance, and Risk] [added: NGR] Committee Chair reports [removed: back] to the full Board after each Committee meeting, including information relating to the cybersecurity discussions.

Our Cybersecurity organization, which includes [removed: corporate and] [added: infrastructure security,] product security, [added: technology risk management, and security awareness and culture] is led by our CISO.

Our CISO, [removed: reporting] [added: reports] directly to our Chief Technology Officer [removed: (“CTO”),] [added: (“CTO”) and] is responsible for developing and implementing our cybersecurity program, including setting the directional security strategy and continuous improvement plans for the overall security program.

Our CISO has over a decade of experience [removed: as a leader of] [added: leading] cyber-security and technology risk management programs in both healthcare and medical device manufacturing [removed: organizations.][added: organizations and maintains multiple industry certifications, including Certified Information Systems Security Professional and Certified Information Security Manager.]

The CTO ensures cyber-security measures are prioritized across research and development, software engineering, and our [removed: IT] [added: information technology] functions.

[removed: Assessing, identifying] [added: Our processes for assessing, identifying,] and managing cybersecurity-related risks [removed: are] [added: is] also [removed: integrated into] [added: included within] our overall enterprise risk management [removed: (“ERM”) process.][added: (ERM) program.]

We have mapped [added: and base-lined] our people, [removed: process,] [added: processes,] and technology in alignment with the categories defined in the NIST industry standard framework: Identify, Protect, Detect, Respond, and Recover.

For the [removed: sixth] [added: seventh] consecutive year, Insulet received re-certification from the ISO, which is the recognized standard for information security management and privacy best practices that adheres to the highest international data security standards.

We regularly assess the threat landscape and take a holistic view of cybersecurity risks, with a layered cybersecurity strategy based on prevention, [removed: detection] [added: detection,] and mitigation.

Interconnectedness between OT technology and other business critical [removed: IT infrastructure can create a material cyber risk.][added: information technology]

Insult deploys segmentation and OT-specific monitoring capabilities to mitigate and monitor this [removed: risk as our OT environment continues to expand to meet the needs of our business.][added: risk.]

In addition to annual trainings, we [removed: have] [added: require and monitor completion of] frequent “nanolearning” targeted trainings.

These quick trainings [removed: encourage participation,] provide constant reminders to our employees to be vigilant and give them the tools to recognize and protect against cyber threats.

We are intensely focused on protecting the security of our products; our guiding principle of [removed: “secure] [added: “security and privacy] by design” underlies all of our product development.

We have a cybersecurity team embedded with our research and development group to deliver on this mission as well as a Product Cybersecurity Risk Management Policy [removed: which is aligned] [added: that aligns] with FDA guidance.

Omnipod 5 incorporates cybersecurity by design principles, which includes secure data transfer between the Pod, Controller, cloud storage, and compatible [removed: continuous glucose monitors.][added: CGMs.]

Omnipod 5 is certified by ISO [removed: 27001] [added: (27001, 27017] and [added: 27799) and] the U.K. Cyber Essentials.

Should a cyber incident occur, we have in place the Insulet Cybersecurity Incident Response Procedure [removed: (“CIRP”),] [added: (“CIRP”) and Crisis Management Plan,] which [removed: is] [added: are] designed to enable us to respond efficiently to any incidents.

Our internal Disclosure Committee [removed: would] [added: will] review any planned public disclosures or filings.

The CTO supports the CISO in chairing a quarterly Technology Risk Committee aimed at providing proper oversight and governance of the cybersecurity program, remediation of identified technology risks, and execution of the cybersecurity strategy.

In 2024, we also added ISO certifications specific to Cloud Computing and Health Informatics, which pairs with and supports other applicable medical device and international certification requirements.

infrastructure can create a material cyber risk.

This experience is coupled with obtaining and maintaining multiple industry certifications, including Certified Information Systems Security Professional certifications (CISSP), and Certified Information Security Manager (CISM).

Cybersecurity-related risks are included in the risk universe that the ERM function evaluates to assess top risks to the enterprise on an annual basis.

To the extent the ERM process identifies a heightened cybersecurity-related risk, risk owners are assigned to develop risk mitigation plans, which are then tracked to completion.

The ERM annual risk assessment is presented to the Board, with additional reporting during the year to the Nominating, Governance and Risk Committee.

[Table](#i5c5eb5e0e38c49dcae99416b1fdf5f72_7) [of Contents](#i5c5eb5e0e38c49dcae99416b1fdf5f72_7)

Omnipod DASH was the first FDA-cleared insulin pump certified under the Diabetes Technology Society’s “Standard for Wireless Diabetes Device Security” cybersecurity assurance standard and program, known as DTSec.

This certification is a cybersecurity standard intended to raise confidence in the security of network connected medical devices through independent expert evaluation.

As of December 31, [removed: 2023,] [added: 2024,] we leased a total of [removed: 13] [added: 11] facilities in [removed: 7] [added: 6] countries consisting of approximately [removed: 282,000] [added: 297,000] square feet of office, research and development, and warehousing space and other related facilities, primarily in North America, Asia and Europe.

[removed: In addition, we leased] [added: We also own] a [removed: 344,000] [added: 400,000] square foot facility in [removed: Malaysia under a finance lease arrangement,] [added: Malaysia,] which houses our new manufacturing facility and office space.

Additional information regarding our leases is provided in Note [removed: 15] [added: 14] to the consolidated financial statements included in Item 8 of this Form 10-K.

[Table](#i5c5eb5e0e38c49dcae99416b1fdf5f72_7) [of Contents](#i5c5eb5e0e38c49dcae99416b1fdf5f72_7)

As of February [removed: 15, 2024,] [added: 13, 2025,] there were 6 registered holders of record of our common stock.

The following graph shows the cumulative total return on $100 invested in each of our common stock, the NASDAQ Composite Index, the NASDAQ Health Care Index, and the S&P 500 Index for the five-year period beginning on December 31, [removed: 2018,] [added: 2019,] and ending on December 31, [removed: 2023,] [added: 2024,] assuming reinvestment of all dividends.

[removed: ][added: ]

| | | | [removed: 2018 | | |] 2019 | | | 2020 | | | 2021 | | | 2022 | | | 2023 | | | [added: 2024 | | |]

| Insulet Corporation | | | $ | 100 | | $ | 149 | | $ | 155 | | $ | 172 | | $ | 127 | | $ | 152 | |

| NASDAQ Composite | | | $ | 100 | | $ | 144 | | $ | 174 | | $ | 117 | | $ | 167 | | $ | 215 | |

| NASDAQ Health Care | | | $ | 100 | | $ | 130 | | $ | 125 | | $ | 100 | | $ | 106 | | $ | 105 | |

| S&P 500(1) | | | $ | 100 | | $ | 118 | | $ | 152 | | $ | 125 | | $ | 158 | | $ | 197 | |

| Insulet Corporation | | | $ | 100 | | $ | 216 | | $ | 322 | | $ | 335 | | $ | 371 | | $ | 274 | |

| NASDAQ Composite | | | $ | 100 | | $ | 135 | | $ | 194 | | $ | 236 | | $ | 158 | | $ | 226 | |

| NASDAQ Health Care | | | $ | 100 | | $ | 126 | | $ | 164 | | $ | 158 | | $ | 126 | | $ | 134 | |

| S&P 500(1) | | | $ | 100 | | $ | 131 | | $ | 156 | | $ | 200 | | $ | 164 | | $ | 207 | |

[Table](#i5c5eb5e0e38c49dcae99416b1fdf5f72_7) [of Contents](#i5c5eb5e0e38c49dcae99416b1fdf5f72_7)

[Table](#i5c5eb5e0e38c49dcae99416b1fdf5f72_7) [of Contents](#i5c5eb5e0e38c49dcae99416b1fdf5f72_7)

Our financial statements as of December 31, [removed: 2023] [added: 2024] and [removed: 2022] [added: 2023] and for each of the three years in the period ended December 31, [removed: 2023,] [added: 2024,] and the Report of the Registered Independent Public Accounting Firm are included in this report as listed in the index.

| [Report of Independent Registered Public Accounting [removed: Firm](#i5c5eb5e0e38c49dcae99416b1fdf5f72_67)] [added: Firm](#i777829bdc5b24aee9c434bde8dd545a5_73)] (PCAOB ID Number 248) | | | [removed: [43](#i5c5eb5e0e38c49dcae99416b1fdf5f72_67)] [added: [42](#i777829bdc5b24aee9c434bde8dd545a5_73)] | | |

| Consolidated Balance Sheets as of December 31, [removed: 2023] [added: 2024] and [removed: 2022] [added: 2023] | | | [removed: [45](#i5c5eb5e0e38c49dcae99416b1fdf5f72_70)] [added: [44](#i777829bdc5b24aee9c434bde8dd545a5_76)] | | |

| Consolidated Statements of [removed: Operations] [added: Income] for the Years ended December 31, [removed: 2023, 2022] [added: 2024, 2023] and [removed: 2021] [added: 2022] | | | [removed: [46](#i5c5eb5e0e38c49dcae99416b1fdf5f72_73)] [added: [45](#i777829bdc5b24aee9c434bde8dd545a5_79)] | | |

| [Consolidated Statements of Comprehensive [removed: I](#i5c5eb5e0e38c49dcae99416b1fdf5f72_76)ncome] [added: I](#i777829bdc5b24aee9c434bde8dd545a5_82)ncome] for the Years ended December 31, [removed: 2023, 2022] [added: 2024, 2023] and [removed: 2021] [added: 2022] | | | [removed: [47](#i5c5eb5e0e38c49dcae99416b1fdf5f72_76)] [added: [46](#i777829bdc5b24aee9c434bde8dd545a5_82)] | | |

| [Consolidated Statements of Stockholders’ Equity for the Years ended December [removed: 31,](#i5c5eb5e0e38c49dcae99416b1fdf5f72_79) 2023, 2022] [added: 31,](#i777829bdc5b24aee9c434bde8dd545a5_85) 2024, 2023] and [removed: 2021] [added: 2022] | | | [removed: [48](#i5c5eb5e0e38c49dcae99416b1fdf5f72_79)] [added: [47](#i777829bdc5b24aee9c434bde8dd545a5_85)] | | |

| [Consolidated Statements of Cash Flows for the Years ended December [removed: 31,](#i5c5eb5e0e38c49dcae99416b1fdf5f72_82) 2023, 2022] [added: 31,](#i777829bdc5b24aee9c434bde8dd545a5_88) 2024, 2023] and [removed: 2021] [added: 2022] | | | [removed: [49](#i5c5eb5e0e38c49dcae99416b1fdf5f72_82)] [added: [48](#i777829bdc5b24aee9c434bde8dd545a5_88)] | | |

| [Notes to Consolidated Financial [removed: Statements](#i5c5eb5e0e38c49dcae99416b1fdf5f72_85)] [added: Statements](#i777829bdc5b24aee9c434bde8dd545a5_91)] | | | [removed: [50](#i5c5eb5e0e38c49dcae99416b1fdf5f72_85)] [added: [49](#i777829bdc5b24aee9c434bde8dd545a5_91)] | | |

We have audited the accompanying consolidated balance sheets of Insulet Corporation (a Delaware corporation) and subsidiaries (the “Company”) as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023, and] the related consolidated statements of [removed: operations,] [added: income,] comprehensive income, [removed: changes in] stockholders’ equity, and cash flows for each of the three years in the period ended December 31, [removed: 2023,] [added: 2024,] and the related notes and financial statement schedule included under Item 15(a) (collectively referred to as the [removed: “financial] [added: “consolidated financial] statements”).

In our opinion, the [added: consolidated] financial statements [added: referred to above] present fairly, in all material respects, the financial position of the Company as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2023] [added: 2024] in conformity with accounting principles generally accepted in the United States of America.

We also have [removed: audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”),] [added: audited] the Company’s internal control over financial reporting as of December 31, [removed: 2023,] [added: 2024,] based on criteria established in the 2013 Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission [removed: (“COSO”), and our report dated February 22, 2024 expressed an adverse opinion.][added: (“COSO”).]

Basis for [removed: opinion][added: opinions]

Our responsibility is to express an opinion on the Company’s [added: consolidated] financial statements [added: and an opinion on the Company’s internal control over financial reporting] based on our audits.

We are a public accounting firm registered with the [removed: PCAOB] [added: Public Company Accounting Oversight Board (United States) (“PCAOB”)] and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

Those standards require that we plan and perform the [removed: audit] [added: audits] to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or [removed: fraud.][added: fraud, and whether effective internal control over financial reporting was maintained in all material respects.]

Our audits [added: of the financial statements] included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.

Critical audit [removed: matters][added: matter]

The critical audit [removed: matters] [added: matter] communicated below [removed: are matters] [added: is a matter] arising from the current period audit of the financial statements that [removed: were] [added: was] communicated or required to be communicated to the audit committee and that: (1) [removed: relate] [added: relates] to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.

The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit [removed: matters] [added: matter] below, providing a separate opinion on the critical audit [removed: matters] [added: matter] or on the accounts or disclosures to which [removed: they relate.][added: it relates.]

Management's estimate is based on historical experience adjusted for revenue growth, trends, [removed: specific known market events,] and [removed: as available channel inventory data.][added: contract amendments.]

- [removed: We tested] [added: Tested] the design and operating effectiveness of controls related to management’s estimate.

| | | | As of December 31, | | | | | | | | | [added: | | | | | |]

| (in millions, except share and per share data) | | | [added: 2024 | | | | | |] 2023 | | | | | | 2022 | | |

| Cash and cash equivalents | | | $ | [removed: 704.2] [added: 953.4] | | | | | $ | [removed: 674.7] [added: 704.2] | |

| Accounts receivable trade, net | | | [removed: 240.2] [added: 252.5] | | | | | | [removed: 140.9] [added: 240.2] | | |

| Accounts receivable trade, net — related party | | | [removed: 119.5] [added: 113.0] | | | | | | [removed: 64.7] [added: 119.5] | | |

| Inventories | | | [removed: 402.6] [added: 430.4] | | | | | | [removed: 346.8] [added: 402.6] | | |

| Prepaid expenses and other current assets | | | [removed: 116.4] [added: 142.0] | | | | | | [removed: 86.9] [added: 116.4] | | |

| Total current assets | | | [removed: 1,582.9] [added: 1,891.3] | | | | | | [removed: 1,314.0] [added: 1,582.9] | | |

| Property, plant and equipment, net | | | [removed: 664.9] [added: 723.1] | | | | | | [removed: 599.9] [added: 664.9] | | |

| Other intangible assets, net | | | [removed: 98.7] [added: 98.5] | | | | | | [removed: 75.5] [added: 98.7] | | |

| Goodwill | | | [removed: 51.7] [added: 51.5] | | | | | | 51.7 | | |

| Total assets | | | $ | [removed: 2,588.2] [added: 3,087.7] | | | | | $ | [removed: 2,251.1] [added: 2,588.2] | |

| Accounts payable | | | $ | [removed: 19.2] [added: 19.8] | | | | | $ | [removed: 30.8] [added: 19.2] | |

| Accrued expenses and other current liabilities | | | [removed: 373.7] [added: 423.8] | | | | | | [removed: 301.0] [added: 373.7] | | |

| Accrued expenses and other current liabilities — related party | | | [removed: 8.9] [added: 1.0] | | | | | | [removed: 5.4] [added: 8.9] | | |

| Current portion of long-term debt | | | [removed: 49.4] [added: 83.8] | | | | | | [removed: 27.5] [added: 49.4] | | |

| Total current liabilities | | | [removed: 451.2] [added: 528.4] | | | | | | [removed: 364.7] [added: 451.2] | | |

| Long-term debt, net | | | [removed: 1,366.4] [added: 1,296.1] | | | | | | [removed: 1,374.3] [added: 1,366.4] | | |

| Other liabilities | | | [removed: 37.9] [added: 51.6] | | | | | | [removed: 35.7] [added: 37.9] | | |

Opinions on the financial statements and internal control over financial reporting

Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2024, based on criteria established in the 2013 Internal Control—Integrated Framework issued by COSO.

The Company’s management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting.

Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk.

Our audits also included performing such other procedures as we considered necessary in the circumstances.

Definition and limitations of internal control over financial reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.

A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

February 20, 2025

| (in millions, except share and per share data) | | | 2024 | | | | | | 2023 | | |

| Deferred tax assets | | | 141.8 | | | | | | $ | 1.8 | |

| Other assets (includes $10.2 and $31.3 at fair value) | | | 181.5 | | | | | | 188.2 | | |

| Other comprehensive loss, net of tax | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (21.2) | | | | | | (21.2) | | |

| Balance, December 31, 2024 | | | 70,196 | | | | | | $ | 0.1 | | | | | $ | 1,184.4 | | | | | $ | 40.3 | | | | | $ | (13.2) | | | | | $ | 1,211.6 | |

| Net income | | | $ | 418.3 | | | | | $ | 206.3 | | | | | $ | 4.6 | |

| Deferred income taxes | | | (136.9) | | | | | | 0.5 | | | | | | (1.0) | | |

| Unrealized loss (gain) on investments | | | 3.8 | | | | | | (2.6) | | | | | | — | | |

| Other | | | 4.9 | | | | | | 2.0 | | | | | | 3.8 | | |

| Proceeds from secured borrowing (Note 6) | | | 45.5 | | | | | | — | | | | | | — | | |

| Repayment of secured borrowing (Note 6) | | | (34.8) | | | | | | — | | | | | | — | | |

| Other | | | — | | | | | | (0.3) | | | | | | — | | |

The Company generates most of its revenue from sales of its Omnipod products.

The Omnipod platform includes: Omnipod® 5 and its predecessors Omnipod DASH and Classic Omnipod.

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.

Following the launch of Omnipod 5, the Company began phasing-out Classic Omnipod.

Investments in equity securities are recorded within other assets on the consolidated balance sheets.

Additional information on the Company’s derivative instruments is included in Note 17 and fair values are included in Note 16.

Lease terms may include options to extend and/or terminate the lease.

The Company generates revenue from the sale of its Controller/PDM and Pods.

We generally recognize revenue when control is transferred to our customers in an amount that reflects the net consideration to which we expect to be entitled.

In determining how revenue should be recognized, a five-step process is used, which includes identifying performance obligations in the contract, determining whether the performance obligations are separate, allocating the transaction price to each separate performance obligation, estimating the amount of variable consideration to include in the transaction price, and determining the timing of revenue recognition for separate performance obligations.

*•Contracts and Performance Obligations.* The Company generally considers customer purchase orders, which in most cases are governed by agreements with distributors or third-party payors, to be contracts with a customer.

The Company considers the obligation to transfer the Controller/PDM, the initial and subsequent quantity of Pods ordered, and product training, each of which are distinct, to be separate performance obligations.

*•Transaction Price.* Transaction price for the Controller/PDM and Pods reflects the net consideration to which the Company expects to be entitled.

Variable consideration is estimated at the outset of the contract and includes, but is not limited to reductions for: consideration payable to customers, such as rebates, chargebacks, and administrative fees paid to distributors; product returns provision; prompt payment discounts; and various other promotional or incentive arrangements.

If a contract contains more than one performance obligation, the transaction price is allocated to each performance obligation based on relative standalone selling price.

*•Rebates.* The Company is subject to rebates on pricing programs with managed care organizations, such as pharmacy benefit managers, governmental and third-party commercial payors, primarily in the United States.

The Company estimates provisions for rebates primarily based on historical experience, revenue growth, distribution channel lag, and known events or trends.

[Table](#i5c5eb5e0e38c49dcae99416b1fdf5f72_7) [of Contents](#i5c5eb5e0e38c49dcae99416b1fdf5f72_7)

Opinion on the financial statements

These financial statements are the responsibility of the Company’s management.

*Income taxes – Realizability of the U.S. deferred tax assets*

As described further in Note 23 to the financial statements, management records valuation allowances against deferred tax assets when a judgment is made, that it is more likely than not, that a tax benefit will not be realized.

The realization of deferred tax assets is dependent upon the generation of future U.S. taxable income during the periods in which those temporary differences will become deductible.

We identified the realizability of the Company’s U.S. deferred tax assets as a critical audit matter.

The principal consideration for our determination that the realizability of U.S. deferred tax assets is a critical audit matter is the significant judgment regarding the weighting of available positive and negative evidence to determine that the existing valuation allowance on U.S. deferred tax assets remains appropriate.

Our audit procedures related to the realizability of the U.S. deferred tax assets included the following, among others.

With the involvement of tax professionals, including consultation with national office resources, we assessed the appropriateness of management’s evaluation of available positive and negative evidence supporting the valuation allowance position.

February 22, 2024

| | | | | | | | | | | | |

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Other assets | | | 190.0 | | | | | | 210.0 | | |

| Loss on extinguishment of debt | | | — | | | | | | — | | | | | | (42.4) | | |

| Balance, December 31, 2020 | | | 66,017 | | | | | | $ | 0.1 | | | | | $ | 1,264.3 | | | | | $ | (666.3) | | | | | $ | 5.5 | | | | | $ | 603.6 | |

| Extinguishment of conversion feature on 1.375% Notes, net of issuance costs | | | — | | | | | | — | | | | | | (808.5) | | | | | | — | | | | | | — | | | | | | (808.5) | | |

| Issuance of shares for debt extinguishment | | | 2,586 | | | | | | — | | | | | | 722.4 | | | | | | — | | | | | | — | | | | | | 722.4 | | |

| Loss on extinguishment of convertible debt | | | — | | | | | | — | | | | | | 42.4 | | |

| Other | | | (0.1) | | | | | | 2.8 | | | | | | 1.2 | | |

| Receipts from the maturity or sale of marketable securities | | | — | | | | | | — | | | | | | 40.0 | | |

| Repayment of convertible debt | | | — | | | | | | — | | | | | | (460.9) | | |

| Proceeds from equipment financings, net | | | — | | | | | | — | | | | | | 43.1 | | |

| Payment of debt issuance costs | | | (0.3) | | | | | | — | | | | | | (4.0) | | |

Currently, the Omnipod platform’s revenue generating products include: the Omnipod Insulin Management System (“Classic Omnipod”), its next generation Omnipod DASH® Insulin Management System (“Omnipod DASH”), and its newest generation Omnipod® 5 Automated Insulin Delivery System (“Omnipod 5”).

Restricted cash required to be set aside in connection with equipment financings or that serves as collateral for outstanding letters of credit and bank guarantees is included in other assets and cash and cash equivalents on the consolidated balance sheet.

impairment.

Lease agreements generally have lease and non-lease components, which are accounted for separately.

Certain leases may contain variable lease payments, including periodic payments that can be avoided by the Company.

Variable payments that do not depend on an index or rate are excluded from the right-of-use asset and lease liability and are recognized as expenses in the period in which the obligation for those payments is incurred.

Certain of the Company’s leases contain options to extend and/or terminate the lease, and/or to purchase the underlying asset.

For finance leases, the right-of-use asset is amortized to amortization expense and interest expense is recorded in connection with the lease liability.

The

Revenue is recognized when a customer obtains control of the promised products.

The amount of revenue recognized reflects the consideration the Company expects to be entitled to receive in exchange for these products.

To achieve this core principle, the Company applies the following five steps:

*•Identify Contracts with Customers.* The Company’s contracts with its direct customers generally consist of a physician order form, a customer information form and, if applicable, third-party insurance (payor) approval.

Contracts with the Company’s intermediaries are generally in the form of master service agreements against which firm purchase orders are issued.

At the outset of the contract, the Company assesses the customer’s ability and intention to pay, which is based on a variety of factors including historical payment experience or, in the case of a new intermediary, credit references and other available financial information pertaining to the customer and, in the case of a new direct customer, an investigation of insurance eligibility.

*•Identify Performance Obligations.* The performance obligations in contracts for the delivery of Omnipod products to new end-users, either directly to end-users or through intermediaries, primarily consist of the PDM/Controller, the initial and subsequent quantity of Pods ordered, and product training.

Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, [removed: 2023.][added: 2024.]

Based on the evaluation of our disclosure controls and procedures as of December 31, [removed: 2023,] [added: 2024,] our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were [removed: not] effective [removed: due to the material weakness identified and described below.][added: at a reasonable assurance level.]

[removed: *Management’s Annual Report on Internal Control Over Financial Reporting*][added: Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2024.]

[removed: -] [added: We obtained and evaluated a service auditor’s report on the] ITGCs over [removed: the] [added: a] system used by an outsourced [removed: provider, and][added: service provider outside of North America.]

The effectiveness of our internal control over financial reporting as of December 31, [removed: 2023] [added: 2024] has been audited by Grant Thornton LLP, an independent registered public accounting firm.

[removed: There] [added: Other than the actions taken to remediate the material weakness described above, there] were no changes in our internal control over financial reporting during the three months ended December 31, [removed: 2023] [added: 2024] that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Based on our assessment, we believe that our internal controls over financial reporting were effective as of December 31, 2024.

*Remediation of Previously Reported Material Weakness*

As previously reported in Part II, *Item 9A, Controls and Procedures* of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission on February 22, 2024, in connection with our assessment of the effectiveness of internal control over financial reporting as of December 31, 2023, we identified a material weakness related to ineffective information technology general controls (“ITGCs”) around systems that support the Company’s financial reporting outside of North America.

In response to the material weakness, the Company developed and implemented a remediation plan.

Based on those remediation actions, management has concluded that the material weakness previously reported has been remediated as of December 31, 2024.

We also enhanced our security access controls over our newly implemented enterprise resource planning system.

Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2023.

Based on this evaluation, our chief executive officer and chief financial officer have concluded that during the period covered by this report, our internal control over financial reporting was not effective, due to a material weakness relating to information technology general controls (“ITGCs”).

Specifically, the Company did not design and maintain effective ITGCs around systems that support the Company’s financial reporting outside of North America.

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis.

Notwithstanding such material weakness in internal control over financial reporting, our management, including our chief executive officer and our chief financial officer, has concluded that our consolidated financial statements present fairly, in all material respects, our financial position, results of our operations and our cash flows for the periods presented in this Form 10-K, in conformity with GAAP.

Management is currently taking actions to remediate the deficiencies in its internal controls over financial reporting and is implementing additional processes and controls designed to address the underlying causes associated with the above-mentioned material weakness.

Management is committed to remediating the deficiencies described above.

Internal control remediation efforts are expected to include establishing and maintaining the following:

- ITGCs over the Company’s newly implemented enterprise resource planning system outside of North America related to security access controls.

Management believes that these actions will remediate the material weakness.

The weakness will not be considered remediated, however, until the applicable controls operate and management has concluded, through testing, that these controls are operating effectively.

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

Board of Directors and Shareholders

Insulet Corporation

Opinion on internal control over financial reporting

We have audited the internal control over financial reporting of Insulet Corporation (a Delaware corporation) and subsidiaries (the “Company”) as of December 31, 2023, based on criteria established in the 2013 *Internal Control—Integrated Framework* issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”).

In our opinion, because of the effect of the material weakness described in the following paragraphs on the achievement of the objectives of the control criteria, the Company has not maintained effective internal control over financial reporting as of December 31, 2023, based on criteria established in the 2013 *Internal Control—Integrated Framework* issued by COSO.

A material weakness is a deficiency, or combination of control deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis.

The following material weakness has been identified and included in management’s assessment.

The Company did not maintain effective Information Technology General Controls (“ITGCs”) around systems that support the Company’s financial reporting outside of North America.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the consolidated financial statements of the Company as of and for the year ended December 31, 2023.

The material weakness identified above was considered in determining the nature, timing, and extent of audit tests applied in our audit of the 2023 consolidated financial statements, and this report does not affect our report dated February 22, 2024 which expressed an unqualified opinion on those financial statements.

Basis for opinion

The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting.

Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.

We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.

Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances.

We believe that our audit provides a reasonable basis for our opinion.

Definition and limitations of internal control over financial reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.

A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Other information

We do not express an opinion or any other form of assurance on the remediation plans or related actions described in Management’s Annual Report on Internal Control Over Financial Reporting.

/s/ GRANT THORNTON LLP

Boston, Massachusetts

February 22, 2024

On [removed: November 23, 2023, Prem Singh, the Company’s Senior Vice President, Global Operations,] [added: December 3, 2024, Wayne A. I. Frederick, a member of our Board of Directors,] adopted a [added: written] trading plan intended to satisfy Rule 10b5-1(c) under the Exchange Act to sell up to [removed: 775] [added: 1,825] shares of our common stock between [removed: February 23, 2024] [added: March 5, 2025] and [removed: November 22, 2024, the date this plan expires.][added: December 31, 2025.]

The trading plan will [removed: cease] [added: terminate] upon the earlier of [removed: November 22, 2024] [added: December 31, 2025,] or the sale of all shares subject to the trading plan.

During the fourth quarter of [removed: 2023, none of our] [added: 2024, no] other [removed: executive officers] [added: director] and none of our [removed: directors] [added: executive officers] 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.

The information required by this Item will be set forth in our definitive proxy statement for our [removed: 2024] [added: 2025] Annual Meeting of Stockholders (the “Proxy Statement”) and is incorporated herein by reference.

The following table sets forth information regarding securities authorized for issuance under our equity compensation plans as of December 31, [removed: 2023.][added: 2024.]

As of December 31, [removed: 2023, 494,126] [added: 2024, 629,518] restricted stock units were outstanding.

The weighted-average exercise price of outstanding options as of such date issued under these Plans (excluding restricted stock units) was [removed: $135.37.][added: $155.65.]

For more information relating to our equity compensation plans, see Note [removed: 20] [added: 19] to our consolidated financial statements.

| Equity compensation plans approved by security holders(1) | | | 399,396 | | | | | | $ | 155.65 | | | | | 1,646,720 | | | (2) | | |

| Total | | | 399,396 | | | | | | $ | 155.65 | | | | | 1,646,720 | | | | | |

| Equity compensation plans approved by security holders(1) | | | 436,094 | | | | | | $ | 135.37 | | | | | 2,524,732 | | | (2) | | |

| Total | | | 436,094 | | | | | | $ | 135.37 | | | | | 2,524,732 | | | | | |

| 3.1 | | | [Eighth Amended and Restated Certificate of Incorporation of the Registrant (Incorporated by reference to Exhibit 3.1 to our Registration Statement on Form S-8 (No. 333-144636) filed July 17, [removed: 2007)](http://www.sec.gov/Archives/edgar/data/1145197/000095013507004336/b66092icexv3w1.txt)] [added: 2007)](https://www.sec.gov/Archives/edgar/data/1145197/000095013507004336/b66092icexv3w1.txt)] | | |

| 4.1 | | | [Specimen Stock Certificate (Incorporated by reference to Exhibit 4.1 to Amendment No.2 to our Registration Statement on Form S-1 (File No. 333-140694) filed April 25, [removed: 2007)](http://www.sec.gov/Archives/edgar/data/1145197/000095013507002416/b63591a2exv4w1.htm)] [added: 2007)](https://www.sec.gov/Archives/edgar/data/1145197/000095013507002416/b63591a2exv4w1.htm)] | | |

| 4.2 | | | [Indenture, dated as of September 6, 2019, between Insulet Corporation and Wells Fargo Bank, National Association, as Trustee (Incorporated by reference to Exhibit 4.1 to our Current Report on Form 8-K filed September 9, [removed: 2019).](http://www.sec.gov/Archives/edgar/data/1145197/000119312519240972/d766132dex41.htm)] [added: 2019).](https://www.sec.gov/Archives/edgar/data/1145197/000119312519240972/d766132dex41.htm)] | | |

| 4.3 | | | [Form of 0.375% Convertible Notes due 2026 (included in Exhibit 4.1 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2019, filed November 5, [removed: 2019)](http://www.sec.gov/Archives/edgar/data/1145197/000119312519240972/d766132dex41.htm)] [added: 2019)](https://www.sec.gov/Archives/edgar/data/1145197/000119312519240972/d766132dex41.htm)] | | |

| 10.1* | | | [Insulet Corporation 2017 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed May 19, [removed: 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000115752317001624/a51562187_ex101.htm)] [added: 2017)](https://www.sec.gov/Archives/edgar/data/1145197/000115752317001624/a51562187_ex101.htm)] | | |

| 10.2* | | | [Form of Insulet Corporation 2017 Stock Option and Incentive Plan Incentive Stock Option Agreement for Employees (Incorporated by reference to Exhibit 10.4 to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2017, filed August 4, [removed: 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000013/podd-exx104_20170630x10q.htm)] [added: 2017)](https://www.sec.gov/Archives/edgar/data/1145197/000114519717000013/podd-exx104_20170630x10q.htm)] | | |

| 10.3* | | | [Form of Insulet Corporation 2017 Stock Option and Incentive Plan Non-Qualified Stock Option Agreement for Employees (Incorporated by reference to Exhibit 10.5 to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2017, filed August 4, [removed: 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000013/podd-exx105_20170630x10q.htm)] [added: 2017)](https://www.sec.gov/Archives/edgar/data/1145197/000114519717000013/podd-exx105_20170630x10q.htm)] | | |

| 10.6* | | | [Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Appendix A to our Definitive Proxy Statement on Schedule 14A filed on April 2, [removed: 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000119312515117872/d864077ddef14a.htm#toc864077_12)] [added: 2015)](https://www.sec.gov/Archives/edgar/data/1145197/000119312515117872/d864077ddef14a.htm#toc864077_12)] | | |

| 10.7* | | | [Form of Executive Officer 3 Year Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.7 to our Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2017, filed May 9, [removed: 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000009/podd-exx107_2017331x10q.htm)] [added: 2017)](https://www.sec.gov/Archives/edgar/data/1145197/000114519717000009/podd-exx107_2017331x10q.htm)] | | |

| 10.8* | | | [Form of Non-Qualified Stock Option Agreement for Non-Employee Directors under the Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.3 to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2016, filed August 4, [removed: 2016](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000094/podd-exx103_20160630x10q.htm))] [added: 2016](https://www.sec.gov/Archives/edgar/data/1145197/000114519716000094/podd-exx103_20160630x10q.htm))] | | |

| 10.9* | | | [Form of Non-Executive Employee Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.60 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed February 29, [removed: 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1060_20151231x10k.htm)] [added: 2016)](https://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1060_20151231x10k.htm)] | | |

| 10.10* | | | [Form of Section 16 Officer Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.62 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed February 29, [removed: 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1062_20151231x10k.htm)] [added: 2016)](https://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1062_20151231x10k.htm)] | | |

| 10.11* | | | [Form of Vice President Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.64 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed February 29, [removed: 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1064_20151231x10k.htm)] [added: 2016)](https://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1064_20151231x10k.htm)] | | |

| 10.12* | | | [Form of Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.4 to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2015, filed August 12, [removed: 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000059/podd-ex104_20150630x10q.htm)] [added: 2015)](https://www.sec.gov/Archives/edgar/data/1145197/000114519715000059/podd-ex104_20150630x10q.htm)] | | |

| 10.13* | | | [Form of Incentive Stock Option Agreement under the Second Amended and Restated 2007 Stock Option and Incentive Plan - 2015 Sales Plan (Incorporated by reference to Exhibit 10.51 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2014, filed February 26, [removed: 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000020/poddex1051_2014311210k.htm)] [added: 2015)](https://www.sec.gov/Archives/edgar/data/1145197/000114519715000020/poddex1051_2014311210k.htm)] | | |

| 10.14* | | | [Form of Non-Qualified Stock Option Agreement for Company Employees under the Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.4 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2014, filed November 5, [removed: 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex104_20140930x10q.htm)] [added: 2014)](https://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex104_20140930x10q.htm)] | | |

| 10.15* | | | [Form of Non-Qualified Stock Option Agreement for Non-Employee Directors under the Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.5 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2014, filed November 5, [removed: 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex105_20140930x10q.htm)] [added: 2014)](https://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex105_20140930x10q.htm)] | | |

| 10.16* | | | [Form of Incentive Stock Option Agreement under the Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.7 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2014, filed November 5, [removed: 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex107_20140930x10q.htm)] [added: 2014)](https://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex107_20140930x10q.htm)] | | |

| 10.17* | | | [Form of Incentive Stock Option Agreement for Section 16 Officers under the Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.10 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2014, filed November 5, [removed: 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex1010_20140930x10q.htm)] [added: 2014)](https://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex1010_20140930x10q.htm)] | | |

| 10.18* | | | [Form of Non-Qualified Stock Option Agreement for Section 16 Officers under the Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.11 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2014, filed November 5, [removed: 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex1011_20140930x10q.htm)] [added: 2014)](https://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex1011_20140930x10q.htm)] | | |

| 10.19* | | | [Form of Incentive Stock Option Agreement under the Second Amended and Restated 2007 Stock Option and Incentive Plan - October 2014 New Hires (Incorporated by reference to Exhibit 10.15 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2014, filed November 5, [removed: 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd_ex1015x20140903-10q.htm)] [added: 2014)](https://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd_ex1015x20140903-10q.htm)] | | |

| [removed: 10.23*] [added: 10.26*] | | | [Annual Incentive Compensation Plan (Incorporated by reference to Exhibit 10.5 to our Current Report on Form 8-K, filed February 22, 2023)](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000011/podd-2023x02x22ex105.htm) | | |

| [removed: 10.24*] [added: 10.27*] | | | [Amended and Restated Executive Severance Plan (Incorporated by reference to Exhibit 10.4 to our Current Report on Form 8-K filed February 22, 2023)](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000011/podd-2023x02x22ex104.htm) | | |

| [removed: 10.25*] [added: 10.28*] | | | [Insulet Corporation Employee Stock Purchase Plan (Amended and Restated February 27, 2019) (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed May 30, [removed: 2019)](http://www.sec.gov/Archives/edgar/data/1145197/000114519719000023/insuletcorporationemployee.htm)] [added: 2019)](https://www.sec.gov/Archives/edgar/data/1145197/000114519719000023/insuletcorporationemployee.htm)] | | |

| [removed: 10.26*] [added: 10.29*] | | | [Insulet Corporation Deferred Compensation Plan for Non-Employee Directors (incorporated by reference to Exhibit 10.1 to our Registration Statement on Form S-8, filed on November 2, 2023)](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000074/ex-101.htm) | | |

| [removed: 10.27*] [added: 10.30*] | | | [Form of Inventions, Non-Disclosure, Non-Solicitation, Non-Servicing and Non-Competition Agreement (Executive Officers other than Jim Hollingshead and Dan Manea) (Incorporated by reference to Exhibit [removed: 10.](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1030_20221231x.htm)[30](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1030_20221231x.htm) [to] [added: 10.30 to] our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed February 24, 2023)](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1030_20221231x.htm) | | |

| [removed: 10.28*] [added: 10.31*] | | | [Form of Confidentiality, Non-Solicit, Non-Compete, and IP Assignment Agreement, by and between the Company and Employee (Jim Hollingshead and Dan Manea) (Incorporated by reference to Exhibit [removed: 10.](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1066_20221231x.htm)[66](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1066_20221231x.htm) [to] [added: 10.66 to] our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed February 24, 2023)](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000020/podd2022-ex1066_20221231x.htm) | | |

| [removed: 10.29*] [added: 10.32*] | | | [Offer Letter between John W. Kapples and Insulet Corporation, dated January 22, 2019 (Incorporated by reference to Exhibit 10.2 to our Quarterly Report on Form 10-Q, filed May 3, [removed: 2019).](http://www.sec.gov/Archives/edgar/data/1145197/000114519719000020/podd-exx102_20190331x10q.htm)] [added: 2019).](https://www.sec.gov/Archives/edgar/data/1145197/000114519719000020/podd-exx102_20190331x10q.htm)] | | |

| [removed: 10.30*] [added: 10.33*] | | | [Offer Letter between Dan Manea and Insulet Corporation, dated March 19, 2020 (Incorporated by reference to Exhibit 10.56 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed February 24, 2021).](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1056_20201231x10k.htm) | | |

| [removed: 10.31*] [added: 10.34*] | | | [Offer Letter between James R. Hollingshead and Insulet Corporation, dated May 4, 2022 (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed May 6, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex101.htm) | | |

| [removed: 10.32*] [added: 10.58++] | | | [removed: [Retirement and Advisory] [added: [Data] Agreement [removed: between Shacey Petrovic] [added: by] and [added: between] Insulet [removed: Corporation,] [added: Corporation and DexCom, Inc,] dated May [removed: 4, 2022] [added: 7, 2020] (Incorporated by reference to Exhibit [removed: 10.2] [added: 10.4] to our [removed: Current] [added: Quarterly] Report on Form [removed: 8-K,] [added: 10-Q for the fiscal quarter ended June 30, 2022,] filed [removed: May 6, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex102.htm)] [added: August 5, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx104_2022x06x30x10q.htm)] | | |

| [removed: 10.33#] [added: 10.35*] | | | [removed: [Tempor](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000011/podd-exx1033_20231231x10k.htm)[ary] [added: [Temporary] Acting Up [removed: Agre](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000011/podd-exx1033_20231231x10k.htm)[ement between](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000011/podd-exx1033_20231231x10k.htm) [Lauren] [added: Agreement between Lauren] Budden and Insulet Corporation, [removed: dated](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000011/podd-exx1033_20231231x10k.htm) [October](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000011/podd-exx1033_20231231x10k.htm) [](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000011/podd-exx1033_20231231x10k.htm)[30](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000011/podd-exx1033_20231231x10k.htm)[, 202](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000011/podd-exx1033_20231231x10k.htm)[3](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000011/podd-exx1033_20231231x10k.htm)[.](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000011/podd-exx1033_20231231x10k.htm)] [added: dated October 30, 2023 (Incorporated by reference to Exhibit 10.33 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed February 2](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000011/podd-exx1033_20231231x10k.htm)[3](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000011/podd-exx1033_20231231x10k.htm)[, 2024)](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000011/podd-exx1033_20231231x10k.htm)[.](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000011/podd-exx1033_20231231x10k.htm)] | | |

| [removed: 10.34] [added: 10.36] | | | [Form of Capped Call Transactions Confirmation (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed September 9, 2019)](https://www.sec.gov/Archives/edgar/data/1145197/000119312519240972/d766132dex101.htm) | | |

| [removed: 10.35] [added: 10.37] | | | [Credit Agreement, dated as of May 4, 2021, by and among Insulet Corporation, the lenders and other parties party thereto and Morgan Stanley Senior Funding, Inc., as administrative agent and collateral agent (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed May 5, 2021).](https://www.sec.gov/Archives/edgar/data/1145197/000119312521150953/d180998dex101.htm) | | |

| [removed: 10.36] [added: 10.38] | | | [Incremental Amendment to Credit Agreement, dated June 15, 2022, 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 June 16, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000119312522174941/d477416dex101.htm) | | |

| [removed: 10.37] [added: 10.39] | | | [Second Amendment to Credit Agreement, dated November 30, 2022, between Insulet Corporation and Morgan Stanley Senior Funding, Inc., as administrative agent (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed December 1, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000119312522295969/d420238dex101.htm) | | |

| [removed: 10.38] [added: 10.40] | | | [Third Amendment to Credit Agreement, dated November 30, 2022, between Insulet Corporation, Insulet MA Securities Corporation, the lenders and other parties thereto and Morgan Stanley Senior Funding, Inc., as administrative agent (Incorporated by reference to Exhibit 10.2 to our Current Report on Form 8-K, filed December 1, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000119312522295969/d420238dex102.htm) | | |

| [removed: 10.39] [added: 10.41] | | | [Fourth Amendment to Credit Agreement, dated June 9, 2023, 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 the Company's Current Report on Form 8-K filed June 9, 2023)](https://www.sec.gov/Archives/edgar/data/1145197/000119312523164934/d348165dex101.htm) | | |

| [removed: 10.40] [added: 10.42] | | | [Fifth Amendment to Credit Agreement, dated [removed: January](https://www.sec.gov/Archives/edgar/data/1145197/000119312524014842/d730170dex101.htm) [2](https://www.sec.gov/Archives/edgar/data/1145197/000119312524014842/d730170dex101.htm)[4](https://www.sec.gov/Archives/edgar/data/1145197/000119312524014842/d730170dex101.htm)[,] [added: January 24,] 2024, among Insulet Corporation, Insulet MA Securities Corporation, Morgan Stanley Senior Funding, Inc., as administrative agent, and the other lenders party thereto (Incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed [removed: January](https://www.sec.gov/Archives/edgar/data/1145197/000119312524014842/d730170dex101.htm) [2](https://www.sec.gov/Archives/edgar/data/1145197/000119312524014842/d730170dex101.htm)[5](https://www.sec.gov/Archives/edgar/data/1145197/000119312524014842/d730170dex101.htm)[,] [added: January 25,] 2024)](https://www.sec.gov/Archives/edgar/data/1145197/000119312524014842/d730170dex101.htm) | | |

| [removed: 10.41] [added: 10.44] | | | [Purchase and Sale Agreement by and between 100 Nagog Park Limited Partnership and Insulet Corporation, dated December 16, 2016 (Incorporated by reference to Exhibit 1.1 to our Current Report on Form 8-K filed December 20, 2016 (Items 1.01 and 9.01)](https://www.sec.gov/Archives/edgar/data/1145197/000115752316007605/a51481585ex1_1.htm) | | |

| 10.23* | | | [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 March 1, 2024)](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000013/podd-2024x02x29ex101.htm) | | |

| 10.24* | | | [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 March 1, 2024)](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000013/podd-2024x02x29ex102.htm) | | |

| 10.25* | | | [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 March 1, 2024)](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000013/podd-2024x02x29ex103.htm) | | |

| 10.43 | | | [Sixth Amendment to Credit Agreement, dated August 2, 2024, among Insulet Corporation, Insulet MA Securities Corporation, Morgan Stanley Senior Funding, Inc., as administrative agent, and the other lenders party thereto (Incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed August 5, 2024)](https://www.sec.gov/Archives/edgar/data/1145197/000119312524193356/d878251dex101.htm) | | |

| 10.62++ | | | [Amendment No. 3, dated as of March 20, 2024, to the Amended and Restated Development and Commercialization Agreement by and between Insulet Corporation and Abbott Diabetes Care Inc. dated as of September 13, 2021 (Incorporated by reference to Exhibit 10.3 to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2024, filed August 9, 2024).](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000039/podd-exx103x2024x06x30_10q.htm) | | |

| 10.66++ | | | [Addendum, dated as of May 15, 2024, 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 the Company's Current Report on Form 8-K filed May 20, 2024).](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000024/podd-2024x05x20ex101.htm) | | |

| 10.71 | | | [Offer Letter between Ana Maria Chadwick and Insulet Corporation dated March 4, 2024 (Incorporated by reference to Exhibit 10.](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000022/podd-exx101x2024x03x31_10q.htm)[1](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000022/podd-exx101x2024x03x31_10q.htm) [to our Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2024, filed May 10, 2024)](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000022/podd-exx101x2024x03x31_10q.htm) | | |

| 19.1# | | | [Insulet Co](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000007/podd-exx191_20241231x10k.htm)[rporation Amended and Restated Ins](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000007/podd-exx191_20241231x10k.htm)[ider Trading Policy](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000007/podd-exx191_20241231x10k.htm) | | |

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| February [removed: 22, 2024] [added: 20, 2025] | | | /s/ James R. Hollingshead | | |

| | | | [removed: Interim] Chief Financial Officer, [removed: Group] [added: Executive] Vice [removed: President, Chief Accounting Officer and Controller (duly authorized officer and Principal] [added: President (Principal] Financial [removed: and Accounting] Officer) | | |

Hollingshead and [removed: Lauren D.][added: Ana M.]

[removed: Budden,] [added: Chadwick,] and each of them singly, our true and lawful attorneys, with full power to them and each of them singly, to sign for us in our names in the capacities indicated below, on all amendments to this Report, and generally to do all things in our names and on our behalf in such capacities to enable Insulet Corporation to comply with the provisions of the Securities Exchange Act of 1934, as amended, and all requirements of the Securities and Exchange Commission.

Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant and in the capacities on February [removed: 22, 2024.][added: 20, 2025.]

| /s/ Elizabeth [added: H.] Weatherman | | | | | | | | |

| Elizabeth [added: H.] Weatherman | | | | | | Director | | |

| February 20, 2025 | | | /s/ Ana M. Chadwick | | |

| | | | Ana M. Chadwick | | |

| /s/ Ana M. Chadwick | | | | | | Chief Financial Officer, Executive Vice President | | |

| Ana M. Chadwick | | | | | | (Principal Financial Officer) | | |

| /s/ Flavia H. Pease | | | | | | | | |

| /s/ Timothy C. Stonesifer | | | | | | | | |

| February 22, 2024 | | | /s/ Lauren D. Budden | | |

| | | | Lauren D. Budden | | |

| | | | | | | | | |

| /s/ Lauren D. Budden | | | | | | Interim Chief Financial Officer, Group Vice President, Chief Accounting Officer and Controller | | |

| Lauren D. Budden | | | | | | (Principal Financial and Accounting Officer) | | |

| /s/ Corinne H. Nevinny | | | | | | | | |

| Corinne H. Nevinny | | | | | | Director | | |

| /s/ Shacey Petrovic | | | | | | | | |

| Shacey Petrovic | | | | | | Director | | |