Insulet (PODD) 10-K risk factor changes: FY2025 vs FY2024

Risks Related to Our [removed: Business and Industry][added: Business]

We currently rely on sales of our Omnipod product platform to generate [removed: nearly all] [added: most of] our revenue.

Accordingly, our ability to continue to generate revenue is highly reliant on our ability to [added: successfully] market and sell our Omnipod products [removed: and] to [removed: retain consumers who currently use] [added: new and existing customers, which could be negatively impacted by] the [removed: product.][added: risks described throughout these Risk Factors.]

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

In addition to promoting, marketing, and selling Omnipod products through our own direct sales force, we [removed: also] utilize [removed: domestic and international] intermediaries to distribute our [removed: product to users.][added: product.]

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

If demand for our products [removed: fluctuates] [added: decreases] as a result of economic conditions, competition, [added: perceived inadequate customer service, product performance issues] or otherwise, our ability to [removed: attract and] retain customers could be harmed.

The failure to retain a high percentage of our customers [removed: could] [added: would] negatively impact our revenue growth and may have a material adverse effect on our business, financial condition, and results of operations.

As we continue to expand the number of customers we serve, driven [removed: in large part] by [removed: significant] [added: increasing] demand for Omnipod 5, [added: our international expansion and entrance into the insulin-requiring type 2 diabetes market,] we expect to continue to increase our manufacturing capacity, our personnel, and the scope of our sales and marketing efforts.

[removed: This growth, as well as any other] [added: Our] growth [removed: that we may experience in the future,] will create challenges for our organization and may strain our [removed: management] [added: management, operations,] and [removed: operations resources, including our] customer [removed: service.][added: service resources.]

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

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

Failure to secure or retain adequate coverage or reimbursement for our products by third-party payors could adversely affect our business, [added: revenue,] financial condition, and results of operations.

We expect that sales of our Omnipod [removed: products, which, for Omnipod 5, occur only through the pharmacy channel in the United States and for Omnipod DASH, primarily through the pharmacy channel, will] [added: products would] be limited [removed: unless] [added: if] a substantial portion of their sales price is [added: not] paid for by third-party payors, including private insurance companies, health maintenance organizations, preferred provider organizations, federal and state government healthcare agencies, intermediaries, Medicare, Medicaid, and other managed care providers.

While we anticipate entering into additional contracts with other intermediaries and third-party payors, we cannot [removed: assure] [added: be sure] that our efforts will be [removed: successful, which could limit] [added: successful or that we will be able to maintain these contracts as they can generally be terminated by] the [removed: availability of Omnipod products.][added: third-party payor without cause.]

Moreover, compliance with administrative procedures or requirements of third-party payors may result in delays in [added: the payor] processing approvals [removed: by those payors] for [removed: consumers to obtain] coverage [removed: for the use] of Omnipod [removed: products and for payment to be made for such use.][added: products.]

Failure to secure or retain adequate coverage or reimbursement for our products by third-party payors could [added: limit our ability to expand internationally and] have a material adverse effect on our business, [added: revenue,] financial condition, and results of operations.

Risks Related to [removed: Competition, Product Development] [added: Competition] and [removed: Intellectual Property][added: Product Development]

Our failure to compete effectively would negatively impact our [removed: revenue.][added: revenue and results of operations.]

In addition to the [removed: established] insulin pump competitors, we compete with companies that provide products and supplies for MDI therapy.

Several companies are working to develop and market new insulin “patch” pumps, smart pens, and other methods for the treatment of [added: insulin-dependent] diabetes.

If an existing or future competitor develops a product that competes with or is superior to our Omnipod products, [added: we risk losing] our [added: position as the perceived technology leader in our field, and our] revenue may decline.

If these competitors’ products [removed: were to] gain acceptance by healthcare professionals, people with insulin-dependent diabetes, or third-party payors, we could experience pricing pressure.

In addition, well-capitalized biopharmaceutical companies like Vertex Pharmaceuticals, [added: as well as] the National Institutes of Health, and other supporters of diabetes research, are continually seeking ways to prevent, cure, or improve the treatment of diabetes.

We rely on third parties, such as contract research organizations, medical institutions, clinical investigators, [removed: contract laboratories,] and [removed: other third parties] [added: contract laboratories] to conduct some of our clinical trials and pre-clinical investigations.

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

If [removed: future] clinical trials fail to support the efficacy of our current or future products, our sales may be adversely affected and we may lose an opportunity to secure clinical preference from prescribing [removed: clinicians, which may have a material adverse effect on our business, financial condition, and results of operations.][added: clinicians or reimbursement from third-party payors.]

In addition, [removed: future] clinical studies or articles regarding our existing products or any competing products may be published that either support a claim, or are perceived to support a claim, that a competitor’s product is clinically more effective or easier to use than our products or that our products are not as effective or easy to use as we claim.

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

Any lawsuits that we initiate could be expensive, take significant time, [removed: and divert management’s attention from other business concerns.]

The outcome of litigation to enforce our intellectual property [removed: rights] [added: rights, including the award of damages or other remedies (if any)] is highly unpredictable.

[removed: The occurrence of any] [added: Any] of these events [removed: could] [added: may] have a material adverse effect on our business, financial condition, and results of operations.

[added: In addition, such litigation could] cause [added: negative publicity, cause] product shipment delays, [added: temporarily or permanently] limit or prohibit us from manufacturing, marketing, or selling our current or future products, and/or require us to [added: undertake other remedial activities such as] 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.

If we cannot [removed: retain or] obtain [added: or retain] these agreements, licenses, or other rights, we may not be able to sell, develop, or commercialize our products.

The loss of any of these rights could impair the functionality of our products or prevent us from selling our products without significant development [added: activities] and regulatory [removed: activities] [added: approvals] that may not be completed in time to prevent an interruption in the availability of our products to consumers.

This could result in a material adverse effect on our business, [added: revenue,] financial condition, and results of operations.

We also have a partnership with Glooko that allows our products to connect with Glooko’s cloud-based diabetes data management system so that users and healthcare providers can monitor user data, including insulin delivery [removed: trends] [added: trends,] and blood glucose levels.

Our agreement with Glooko expires in December [removed: 2025.][added: 2026.]

If this agreement is not renewed in the future and we do not [removed: develop or] contract for an alternative data management [removed: system,] [added: system or launch] our [added: own, our] business could be materially adversely impacted.

The continuing worldwide macroeconomic and geopolitical uncertainty as well as the impact of [added: another] global [removed: pandemics] [added: pandemic] may adversely affect our business and prospects.

Failure to continue to successfully market and sell our Omnipod products or to retain and grow our customer base would have a negative impact our business, revenue, financial condition and results of operations.

Further, we anticipate that recently enacted and proposed legislative changes affecting Medicare, Medicaid, and the Affordable Care Act may impact healthcare coverage, which, if implemented could adversely affect both demand for and pricing of our products.

Guidelines for reimbursement vary from jurisdiction to jurisdiction and we may not have the needed experts or clinical evidence within a particular jurisdiction to achieve reimbursement and thereby patient access.

Outside the U.S., several of our major markets have government involvement in their healthcare payment system that may impose negative pricing pressure or limit access to or reimbursement for our products.

We compete with established companies that produce insulin pumps, such as Medtronic Diabetes, a division of Medtronic plc (which division is being spun out into a new, independent publicly traded company), Tandem Diabetes Care Inc., as well as emerging companies like Beta Bionics Inc. Our competitors may develop products in the future that are superior to ours which would inhibit our ability to compete effectively.

A significant element of our strategy is to increase revenue growth by continuing to focus on innovation and new product development.

The results of our product development efforts may be affected by a number of factors, including our ability to anticipate customer needs, innovate and develop new products and technologies, successfully complete clinical trials, obtain regulatory approvals and reimbursement in the U.S. and abroad, gain and maintain market acceptance of our products, manufacture products in a cost-effective manner, and obtain appropriate intellectual property rights.

Further, governmental regulation and laws related to AI and other emerging technologies may increase the burden and cost of research and development or require increased transparency that makes it more difficult to protect our intellectual property.

In addition, patents attained by others can preclude or delay our commercialization of a product.

There can be no assurance that any products currently in development, or that we may seek to develop in the future, will achieve technological feasibility, obtain regulatory approval, or gain market acceptance.

If we are unable to develop and launch new products, our ability to maintain or expand our market position in the markets in which we participate may be negatively impacted.

Even if we successfully develop new products, enhancements, or new generations of existing products, they may be quickly rendered obsolete by changing customer preferences, changing industry or regulatory standards, or competitors’ innovations.

Further, increased availability and adoption of the GLP-1 class of drugs may delay the progression of type 2 diabetes in obese patients.

Risks Related to our Intellectual Property

We may be unable to adequately protect our intellectual property rights, which could limit our ability to sell our products profitably, or at all, and cause us to incur additional costs.

and divert management’s attention from other business concerns.

The occurrence of any of these events could limit our ability to sell our products profitably or at all, or to effectively compete, resulting in a material adverse effect on our business, revenue, financial condition, and results of operations.

Uncertainty about global economic conditions, particularly in countries with government-sponsored healthcare systems, may also cause slower adoption of new technologies such as Omnipod 5.

The international nature of our business subjects us to additional business risks that may have an adverse effect on our financial condition or results of operations.

International expansion is a key component of our growth strategy.

- difficulties in obtaining and maintaining reimbursement from foreign healthcare payment systems on a timely basis or at all;

Expansion of U.S. tariffs could have a material adverse effect on our financial results.

Tariffs, sanctions or other trade barriers imposed by the U.S. (and countermeasures by non-U.S. governments) could adversely impact our supply chain costs or availability of certain components, demand for our products and our business, revenue, financial condition, results of operations and cash flows.

Unpredictability of trade policy compounds this risk.

Further, the U.S. Department of Commerce Bureau of Industry and Security (“BIS”) has announced the initiation of an investigation into the effects on U.S. national security of imports of personal protective equipment, medical consumables, and medical equipment, including medical devices such as insulin pumps.

BIS is conducting the investigation under Section 232 of the Trade Expansion Act of 1962 (Section 232), a law that empowers the president to restrict imports of products that threaten to impair national security.

The investigation could result in overriding the tariff exemption currently in place for certain medical devices, which could have a material impact on our results of operations in future years.

Risks Related to Reliance on Third Parties and Business Continuity

Our inventory is produced and maintained in a limited number of locations, including one operated by a third party in China, and any loss could have a material adverse effect on our ability to manufacture and sell our products.

However, a natural or other disaster, such as a fire or

Our failure to scale manufacturing appropriately to meet future demand, or encountering quality issues or unexpected operational delays when commencing operation of new manufacturing lines, would have an adverse effect on our gross margins and could result in product shortages.

Additionally, inefficient processes can strain relationships with suppliers and partners, further exacerbating operational disruptions and financial losses.

Any delays in obtaining approval for our products, or any failure to meet regulatory requirements could adversely affect our ability to sell our products resulting in a negative impact to our financial results.

If our or our contract manufacturer’s facility fails a quality system inspection or fails to take adequate and timely corrective action in response to an adverse quality system inspection or QSR violation, or otherwise fails to adhere to QSR requirements, this could delay production of our products and lead to business disruption.

However, if the FDA determines that

years.

Further, we expect that the breadth and complexity of our IT systems and infrastructure will increase as we utilize cloud technologies and AI, which present inherent enterprise technology risks, including those related to privacy, data protection, and cybersecurity, that need to be managed.

The foregoing could expose us to further risk of potential breaches, failures, interruptions, and disruptions, which could result in adverse consequences, including regulatory inquiries or litigation, increased costs and expenses, reputational damage, lost revenue, and fines or penalties.

However, ever-evolving threats mean we must continually evaluate and adapt our systems and processes.

In 2025, we had changes in key leadership roles, including our Chief Executive Officer and Chief Financial Officer, among others.

Our sales of Omnipod products may be negatively impacted by many factors, including:

- development of an effective patch pump by one or more competitors or breakthrough diabetes treatments not requiring the delivery of insulin;

- failure of our Omnipod products to achieve and maintain wide acceptance among opinion leaders in the diabetes treatment community, insulin-prescribing physicians, third-party payors, and people with insulin-dependent diabetes;

- manufacturing problems or capacity constraints;

- actual or perceived quality problems;

- reductions in reimbursement rates or coverage policies relating to Omnipod products by third-party payors;

- claims that any portion of Omnipod products infringes on intellectual property rights of others;

- adverse regulatory or legal actions relating to our Omnipod products;

- damage, destruction or loss of any of the facilities where our products are manufactured or stored or of the equipment therein;

- failure to successfully open or expand new facilities;

- the inability of users to continue paying for our products;

- attrition rates of consumers who cease using Omnipod products;

- competitive pricing;

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

- results of clinical studies relating to Omnipod products or our competitors’ products.

If any of these events occur, our ability to generate revenue could be significantly reduced, which would adversely affect our business, financial condition, and results of operations.

We need to expand our distribution network to maintain and grow our business and revenue.

If we are not able to successfully develop our relationships with third-party intermediaries, our sales could fail to grow or could decline, and our ability to grow our business could be adversely affected.

Intermediaries that are in the business of selling other medical products may not devote a sufficient level of resources and the support required to generate awareness of our products and grow or maintain our product sales.

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

Current uncertainty in global economic conditions, competition, higher levels of unemployment, changes in insurance reimbursement levels, and negative financial news may negatively affect product demand.

In order to manage future growth, we will be required to improve existing, and implement new, sales and marketing efforts, distribution channels, and customer support procedures.

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

For example, we recently implemented a new enterprise resource planning system and plan to upgrade our customer relationship management system.

We will also need to manage our supply chain and manufacturing effectively, including our sourcing of materials such as semiconductor chips.

We may also need to partner with additional third-party suppliers to manufacture certain components of our Omnipod products and install additional manufacturing lines, including as a part of our newly constructed facility in Malaysia.

A transition to new suppliers may result in additional costs or delays.

In addition, these contracts can generally be terminated by the third-party payor without cause.

Healthcare market initiatives in the United States may also lead third-party payors to decline or reduce reimbursement for Omnipod products.

We compete with companies that produce insulin pumps, such as Medtronic and Tandem.

In addition, some of our competitors, such as Medtronic, are large, well-capitalized companies with more resources than we have.

These companies may have competitive advantages over us, including:

- significantly greater name recognition;

- different and more complete reimbursement profiles;

- established relations with healthcare professionals, customers, and third-party payors;

- larger and more established distribution networks;

- greater experience in conducting research and development, clinical trials, manufacturing, marketing, and obtaining regulatory approval; and

- greater financial and human resources for product development, sales and marketing, and patent litigation.

As a result, we may not be able to compete effectively against these companies or their products, which may adversely impact our business.

The healthcare industry is characterized by continuous technological change, resulting in changing consumer preferences and requirements.

Factors that could cause or contribute to these differences include those discussed under the headings “Risk Factors” and “Forward-Looking Statements.” [added: Columns and rows within tables may not add due to rounding.]

Our mission is to [removed: improve] [added: transform] the lives of people with diabetes.

The Omnipod platform [removed: includes: the] [added: primarily includes our] most recent generation Omnipod [removed: 5,] [added: 5] and its [removed: predecessors] [added: predecessor] Omnipod [removed: DASH and Classic Omnipod, all of] [added: DASH,] 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 [added: a] color touch screen user interface.

To achieve this, we launched Omnipod 5 in the United States in [removed: 2022 and] [added: 2022,] in the United Kingdom and Germany in [removed: June and August] 2023, [removed: respectively.][added: and in the Netherlands and France in 2024.]

[removed: Additionally, we] [added: We] are [added: also] working on further building our international teams and advancing our regulatory, reimbursement, and market development efforts so we can bring Omnipod 5 to [removed: additional] [added: new] international markets.

Due to the positive results of our Omnipod 5 type 2 pivotal trial and the learnings from our [removed: Omnipod GO] commercial [removed: pilot,] [added: pilot of Omnipod GO, a basal-only Pod for certain individuals with type 2 diabetes,] we made a strategic decision to drive growth in the type 2 diabetes market with Omnipod [removed: 5 and, accordingly, decided not to move forward with the commercialization of Omnipod GO.][added: 5.]

During [removed: 2024,] [added: 2025,] we completed [removed: participant enrollment in] [added: the randomized portion of] our RADIANT study in France, the United Kingdom, and [removed: Belgium, which is our Omnipod 5 with Libre 2 randomized controlled trial.][added: Belgium.]

[removed: Similar to the] [added: The RADIANT study is a] randomized [removed: control] [added: controlled] trial [removed: that we completed in the United States and France for] [added: of] Omnipod 5 with [removed: DexCom’s G6 CGM, the objective is] [added: Libre 2, designed] to provide [added: clinical] data to support our pricing and market access initiatives as we roll out Omnipod 5 with multiple sensors across our international markets.

We [removed: also] continue to focus on our product development efforts, including [removed: AID offerings, such as] choice of smartphone integration and [removed: CGM,] [added: CGM with Omnipod 5] and enhancing the customer experience through digital product and data capabilities.

The discussion of our results of operations for [removed: 2022] [added: 2023] 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: 2023] [added: 2024] filed with the Securities and Exchange Commission on February [removed: 22, 2024.][added: 21, 2025.]

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

The unique patented design of the Omnipod allows us to provide Pod therapy at a relatively low or no up-front investment in regions where reimbursement allows [removed: for it and our pay-as-you-go pricing model reduces the risk to third-party payors.]

Comparison of the Years Ended December 31, [removed: 2024] [added: 2025] and December 31, [removed: 2023][added: 2024]

| (in millions) | | | [removed: 2024] [added: 2025] | | | | | | [removed: 2023] [added: 2024] | | | | | | % Change | | | | | | Currency Impact | | | | | | Constant Currency(1) | | |

| Drug Delivery | | | [removed: 38.9] [added: 34.1] | | | | | | [removed: 36.0] [added: 38.9] | | | | | | [removed: 8.1] [added: (12.3)] | | % | | | | — | | % | | | | [removed: 8.1] [added: (12.3)] | | % |

Total revenue increased [removed: $374.5] [added: $636.6] million, or [removed: 22.1%,] [added: 30.7%,] to [removed: $2,071.6] [added: $2,708.1] million in [removed: 2024,] [added: 2025,] compared with [removed: $1,697.1] [added: $2,071.6] million in [removed: 2023.][added: 2024.]

Constant currency revenue growth of [removed: 21.9%] [added: 29.5%] was primarily driven by higher [added: sales] volume largely attributable to our growing customer base and, to a lesser extent, higher price.

Revenue from the sale of Omnipod products in the U.S. increased [removed: $258.3] [added: $410.5] million, or [removed: 20.6%,] [added: 27.2%,] in [removed: 2024] [added: 2025] to [removed: $1,509.3] [added: $1,919.8] million, compared with [removed: $1,251.0] [added: $1,509.3] million in [removed: 2023.][added: 2024.]

Revenue from the sale of Omnipod products in the U.S. includes [removed: $587.8] [added: $511.6] million of related party revenue in [removed: 2024,] [added: 2025,] compared with [removed: $473.7] [added: $587.8] million in [removed: 2023.][added: 2024.]

Additional information regarding our related party transactions is provided in Note [removed: 5] [added: 2] to our consolidated financial statements.

In [removed: 2025,] [added: 2026,] we expect strong U.S. revenue growth primarily driven by the benefits of our recurring revenue model and continued volume growth of Omnipod 5.

Revenue from the sale of Omnipod products in our international markets increased [removed: $113.3] [added: $230.9] million, or [removed: 27.6%,] [added: 44.1%,] in [removed: 2024] [added: 2025] to [removed: $523.4] [added: $754.3] million, compared with [removed: $410.1] [added: $523.4] million in [removed: 2023.][added: 2024.]

Excluding the [removed: 0.7%] [added: 4.8%] favorable impact of currency exchange, the remaining [removed: 26.9%] [added: 39.3%] increase in revenue was primarily due to higher volumes from [removed: the launches of Omnipod 5 in the United Kingdom and Germany in the prior year, driven by] our growing customer [removed: base and] [added: base, largely resulting from] the [removed: favorable impact] [added: prior year launches] of [removed: conversions to][added: Omnipod 5.]

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

In [removed: 2025,] [added: 2026,] we expect higher International [removed: Omnipod] revenue due to continued volume growth driven by new customers and [added: higher price resulting from] conversions to Omnipod [removed: 5 primarily due to the launch of Omnipod 5 in France and the Netherlands, growth from the earlier launches in Germany and the United Kingdom, and the continued roll out of Omnipod 5 in additional markets.][added: 5.]

| Cost of revenue | | | $ | [removed: 625.9] [added: 768.2] | | | | | [removed: 30.2] [added: 28.4] | | % | | | | $ | [removed: 537.2] [added: 625.9] | | | | | [removed: 31.7] [added: 30.2] | | % |

| Research and development expenses | | | $ | [removed: 219.6] [added: 301.1] | | | | | [removed: 10.6] [added: 11.1] | | % | | | | $ | [removed: 205.0] [added: 219.6] | | | | | [removed: 12.1] [added: 10.6] | | % |

| Selling, general and administrative expenses | | | $ | [removed: 917.2] [added: 1,165.0] | | | | | [removed: 44.3] [added: 43.0] | | % | | | | $ | [removed: 734.9] [added: 917.2] | | | | | [removed: 43.3] [added: 44.3] | | % |

Cost of revenue for [removed: 2024] [added: 2025] increased [removed: $88.7] [added: $142.3] million, or [removed: 16.5%,] [added: 22.7%,] to [removed: $625.9] [added: $768.2] million, compared with [removed: $537.2] [added: $625.9] million in [removed: 2023.][added: 2024.]

Gross margin was [removed: 69.8%] [added: 71.6%] in [removed: 2024,] [added: 2025,] compared with [removed: 68.3%] [added: 69.8%] in [removed: 2023.][added: 2024.]

Research and development expenses increased [removed: $14.6] [added: $81.5] million, or [removed: 7.1%,] [added: 37.1%,] to [removed: $219.6] [added: $301.1] million for [removed: 2024,] [added: 2025,] compared with [removed: $205.0] [added: $219.6] million for [removed: 2023.][added: 2024.]

Selling, general and administrative expenses increased [removed: $182.3] [added: $247.8] million, or [removed: 24.8%,] [added: 27.0%,] to [removed: $917.2] [added: $1,165.0] million in [removed: 2024,] [added: 2025,] compared with [removed: $734.9] [added: $917.2] million in [removed: 2023.][added: 2024.]

This increase was primarily attributable to year-over-year headcount additions to support our [added: business] growth, [removed: international expansion] [added: mainly in our commercial] and [removed: sustain Omnipod 5,] [added: customer experience teams,] and [removed: as a result] [added: incremental advertising expense] of [removed: our new organizational structure.][added: $37.1 million.]

Interest income [removed: increased $10.9] [added: decreased $4.9] million to [removed: $39.5] [added: $34.7] million in [removed: 2024,] [added: 2025,] compared with [removed: $28.6] [added: $39.5] million in [removed: 2023] [added: 2024] primarily driven by [removed: increased average cash balances and higher] [added: lower] interest rates.

*Other [removed: (Expense) Income,] [added: Income (Expense),] net*

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

[removed: *Income Tax Expense*][added: | Income tax expense (benefit) | | | 92.4 | | | | | | (118.1) | | |]

Our effective tax rate was [removed: a benefit of 39.3%] [added: 27.2%] for [removed: 2024,] [added: 2025,] compared with a [removed: provision] [added: tax benefit] of [removed: 3.9%] [added: 39.3%] for [removed: 2023.][added: 2024.]

Amounts have been calculated using actual, non-rounded figures; accordingly, amounts and percentages may not recalculate, and columns and rows within tables may not add due to rounding.

It is indicated for type 1 diabetes and, in the United States, for type 2 diabetes for ages 18 and up.

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.

In 2025, we launched Omnipod 5 in nine additional countries.

In the U.S., we sell our products through the pharmacy channel, which expands access by improving affordable, as no upfront investment is required.

We also continue to increase awareness of Omnipod products through our direct-to-consumer advertising programs.

In 2025, we also completed STRIVE, our pivotal study for the next generation hybrid closed loop system, and we finished enrollment for EVOLUTION 2, our safety and feasibility study for a fully closed loop AID system for type 2 diabetes.

Additionally, we received 510(k) clearance for enhancements to the Omnipod 5 algorithm to include a lower target glucose set point.

We also launched our Omnipod 5 app for iPhone compatible with Dexcom’s G7 CGM sensor in the United States and integrated Omnipod 5 with Dexcom’s G7 CGM sensor in five additional countries and with Abbott’s FreeStyle Libre 2 Plus sensor in Australia.

Following the launch of Omnipod 5 in several countries in the Middle East in early 2026, Omnipod 5 is now available in 19 countries.

We are currently working to integrate Omnipod 5 with Abbott’s FreeStyle Libre 3 Plus and developing Omnipod 6, our next generation AID product.

We began producing product at our new manufacturing plant in Malaysia in 2024 and are already investing in another manufacturing plant in Costa Rica to support our continued growth.

As of December 31, 2025, we had more than 600,000 estimated active Omnipod users globally.

for it and our pay-as-you-go pricing model reduces the risk to third-party payors.

Accordingly, we decided not to move forward with the commercialization of Omnipod GO.

As a result, in 2024, we recorded a charge of $13.5 million related to certain inventory components that would not be utilized.

| U.S. | | | $ | 1,919.8 | | | | | $ | 1,509.3 | | | | | 27.2 | | % | | | | — | | % | | | | 27.2 | | % |

| International | | | 754.3 | | | | | | 523.4 | | | | | | 44.1 | | % | | | | 4.8 | | % | | | | 39.3 | | % |

| Total Omnipod Products | | | 2,674.0 | | | | | | 2,032.7 | | | | | | 31.6 | | % | | | | 1.2 | | % | | | | 30.3 | | % |

| Total | | | $ | 2,708.1 | | | | | $ | 2,071.6 | | | | | 30.7 | | % | | | | 1.2 | | % | | | | 29.5 | | % |

This increase primarily resulted from higher sales volume driven by growing our customer base.

The $76.2 million decrease primarily resulted from one quarter less of related party sales in the current year, partially offset by growth through the pharmacy channel.

Drug Delivery revenue was $34.1 million and $38.9 million in 2025 and 2024, respectively.

| | | | 2025 | | | | | | | | | | | | 2024 | | | | | | | | |

The 180 basis points increase in gross margin was primarily driven by improved manufacturing and supply chain efficiencies, a higher average selling price, increased volume and a $13.5 million charge in the prior year related to certain components utilized in OmnipodGO, which we decided not to commercialize.

While we do not expect tariffs to have a significant impact on our gross margin in 2026, should the exemption that is currently in place for certain medical devices be eliminated, tariffs would have a material impact on our results of operations in future years.

Research and development expenses as a percent of revenue increased to 11.1% in 2025 from 10.6% in 2024.

The increase in research and development expense was primarily due to year-over-year headcount additions to support continued investment in our Omnipod and pipeline products, including a fully closed loop AID system for type 2 diabetes, the integration of Libre 3 with Omnipod 5, and Omnipod 6, our next generation AID system.

To a lesser extent, the increase was driven by higher consulting costs to support our clinical trials and Omnipod and next generation products.

Increased investments in global marketing and training for the sales team to support demand generation also contributed to the increase in selling, general and administrative expenses, although to a lesser extent.

Interest expense increased $16.7 million to $59.4 million in 2025, compared with $42.7 million in 2024 primarily due to the issuance of 6.5% senior unsecured notes in March 2025 and the renewal of interest rate swaps at higher rates in April 2025.

The increase was partially offset by lower interest on our Term Loan B resulting from the refinancing in August 2024 and fees paid to amend our Term Loan B in the prior year, which did not repeat in the current year.

In 2026, we expect net interest expense to increase to $40 million or more, primarily due to lower interest income.

*Loss on Extinguishment of Debt*

During 2025, we repurchased $419.9 million million in principal ($417.6 million net of issuance costs) of our Convertible Senior Notes for $541.5 million in cash, which resulted in a $123.9 million loss on extinguishment.

Other income, net of $14.3 million for 2025 primarily consists of a $12.5 million gain resulting from the change in fair value of the derivative asset associated with the redemption of our convertible debt discussed in Note 15.

*Income Taxes*

The increase in our effective tax rate was primarily due to the absence of a valuation allowance against deferred tax assets that existed in the prior year and the loss

on extinguishment of our Convertible Senior Notes during 2025, the settlement of which resulted in non-deductible premiums, These impacts were partially offset by a nontaxable gain on the related derivative asset.

The Organization for Economic Co-operation and Development (“OECD”) and participating countries continue to advance the implementation of a 15% global minimum corporate tax (“Pillar Two”).

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.

We also continue to expand market access and awareness of Omnipod products through our direct to consumer advertising programs and through growing our presence in the U.S. pharmacy channel, where access to Omnipod 5 and Omnipod DASH is simpler and affordable, as no up-front investment is required.

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.

Similarly, in June 2024 we launched our full market release of Omnipod 5 with Libre 2 Plus for individuals aged two years and older with type 1 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).

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.

We recently achieved a milestone of 500,000 estimated active global customers using Omnipod products, including 365,000 global customers using Omnipod 5.

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.

In 2022, we issued two voluntary Medical Device Correction (“MDC”) notices, one for our Omnipod DASH PDM related to its battery and the other for our Omnipod 5 Controller related to its charging port and cable.

During 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.

| 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 | | % |

This increase primarily resulted from higher volume through the pharmacy channel driven by growing our customer base, partially offset by a decrease in estimated inventory days-on-hand at distributors and lower conversions to Omnipod 5.

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.

The $114.1 million increase primarily resulted from growth through 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.

Omnipod 5.

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.

| | | | 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.

Research and development expenses as a percent of revenue decreased to 10.6% in 2024, compared with 12.1% in 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 2025 to increase compared with 2024 as we continue to invest in advancing our innovation and clinical pipeline.

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.

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

We also plan to make additional investments to support the Omnipod platform and to continue support the phased launch of Omnipod 5 in our existing international markets and prepare for expansion into new countries.

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.

Other income, net of $2.2 million for 2023 consists primarily of $2.6 million of gains related to fair value adjustments associated with our strategic debt and equity investments.

Income tax benefit was $118.1 million on pre-tax income of $300.2 million for 2024, compared with income tax expense of $8.3 million on pre-tax income of $214.6 million for 2023.

Our exposure to changes in interest rates is associated with borrowings under our Revolving Credit Facility and our Term [removed: Loan,] [added: Loan B,] both of which are variable-rate debt.

At December 31, [removed: 2024,] [added: 2025,] no amounts were outstanding under our Revolving Credit Facility.

In [removed: May 2021,] [added: April 2025,] we entered into [removed: two] interest rate swap agreements to effectively convert [removed: $480.0] [added: $460.0] million of our [removed: term loan borrowings] [added: Term Loan B] from a variable rate to a fixed [removed: rate through April 2025.][added: rate.]

A 100 basis point increase or decrease in interest rates as of December 31, [removed: 2024] [added: 2025] would have an insignificant impact on our annual earnings.

Approximately [removed: 25%] [added: 28%] of our revenue was denominated in foreign currencies for the year ended December 31, [removed: 2024.][added: 2025.]

[removed: As our business in regions outside of the United States continues to increase, we] [added: We] will be increasingly exposed to foreign currency exchange risk related to our foreign [removed: operations.][added: operations as our business in regions outside of the United States increases.]

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

At December 31, [removed: 2024,] [added: 2025,] we have intercompany receivables and payables from our foreign subsidiaries that are denominated in their functional currencies, principally the Chinese yuan renminbi.

Net realized and unrealized gains (losses) from foreign currency transactions are included in other [removed: (expense) income,] [added: income (expense),] net in the consolidated statements of income and amounted to a [removed: loss] [added: gain] of [removed: $2.3] [added: $1.8] million for the year ended December 31, [removed: 2024.][added: 2025.]

*Market Price Sensitive Instruments*

As of December 31, 2024, we had outstanding debt related to our Convertible Senior Notes recorded on our consolidated balance sheet of $794.9 million, net of unamortized discount and issuance costs totaling $5.1 million.

Changes in the fair value of our outstanding debt, which could be impacted by changes in interest rates, are not recorded in these consolidated financial statements as the debt is accounted for at cost less unamortized discount and issuance costs.

The fair value of the Convertible Senior Notes, which was $1,018.8 million as of December 31, 2024, is also impacted by changes in our stock price.

In order to reduce potential equity dilution, in connection with the issuance of the Convertible Senior Notes, we 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) if at the time of conversion our stock price exceeds the conversion price under the Convertible Senior Notes.

The Capped Calls have an upper protection price of $335.90 per share and cover 3.5 million shares of common stock.

We estimate that approximately [removed: 5] [added: 6] million people have type 1 diabetes in the countries we currently serve.

Historically, type 2 diabetes has occurred in later adulthood, but its incidence is increasing among [removed: the younger population,] [added: children and young adults,] due primarily to increasing obesity.

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

We estimate that approximately 40% of the type 1 diabetes population in the United States and [removed: 20%] [added: 25%] of the international type 1 diabetes population use insulin pump therapy.

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

Throughout this Annual Report on Form 10-K, we refer to both type 1 diabetes and [removed: insulin-intensive] [added: insulin-requiring] type 2 diabetes as insulin-dependent diabetes.

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

MDI therapy [removed: may] also [removed: require] [added: requires] a separate injection of a long-acting (basal) insulin, to control glucose levels between [removed: meals; typically, once or twice per day.][added: meals.]

For example, insulin pump therapy [added: virtually] eliminates individual insulin injections, delivers insulin more accurately and precisely than injections, often improves HbA1c (a common measure of [added: average] blood glucose [removed: levels)] [added: levels] over [added: time) over] time, provides greater flexibility with meals, exercise, and daily schedules, and can reduce severe low blood glucose levels.

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

The small, lightweight, self-adhesive disposable tubeless Omnipod device (“Pod”), can be worn in multiple locations, including the abdomen, hip, back of upper arm, upper thigh, or lower [removed: back, and delivers insulin into the body through a small flexible tube (called a cannula).][added: back.]

We refer to [removed: this] [added: the delivery of insulin with the Pod] as “Pod therapy.” We believe the Omnipod platform’s innovative proprietary design and differentiated features allow people with insulin-dependent diabetes to live their lives and manage their [removed: diabetes,] [added: diabetes] with unprecedented freedom, comfort, convenience, and ease.

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

Omnipod 5 is [removed: now] [added: currently] available in [removed: 10] [added: 19] countries.

The Pod integrates with a third-party continuous glucose monitor (“CGM”) to obtain glucose values through [added: secure] wireless Bluetooth communication.

The embedded algorithm utilizes these glucose values to predict glucose levels into the future and automatically adjusts insulin dosing intended [removed: to improve time-in-range and reduce the occurrence of blood glucose highs and lows.]

The user can also deliver [added: additional] insulin doses for snacks or meals or to correct high blood glucose through the system.

[added: The Pod can be controlled by an Insulet-provided] handheld device [removed: or] [added: or, in the U.S.,] a user-downloaded Android app [removed: or, in the US, the] [added: or] iOS app, with full smartphone compatibility.

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 [removed: markets as depicted under *Markets and Distribution Methods*.][added: markets.]

Omnipod DASH features a secure [added: wireless] Bluetooth enabled Pod that is controlled by a smartphone-like Personal Diabetes Manager (“PDM”) with a color touch screen user interface.

We have designed Omnipod [removed: DASH] [added: products] to fit within the normal daily routines of users.

Omnipod [removed: DASH communicates wirelessly, provides] [added: products provide] for virtually pain-free automated cannula [removed: insertion, and eliminates] [added: (a small flexible tube) insertion through which insulin is delivered, eliminating] the need for MDI [removed: therapy] or the use of pump and tubing.

We have partnered with Glooko Inc. (“Glooko”) to connect user data with Glooko’s comprehensive diabetes data management system (including [removed: Glooko and] Diasend in selected regions).

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

Third-Party [added: Coverage and] Reimbursement

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

Reimbursement structures vary by country and our unique offering allows us to provide Pod therapy in attractive pricing structures that reduce the risk to payors while expanding [removed: access.][added: access to consumers.]

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

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

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

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

For the year ended December 31, [removed: 2024, 88%] [added: 2025, 86%] of Omnipod product sales globally were through intermediaries.

| | | | [removed: 2024] [added: 2025] | | | | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | |

| Distributor A | | | [removed: 28%] [added: 27%] | | | | | | 28% | | | | | | [removed: 19%] [added: 28%] | | |

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

| Distributor C | | | [removed: 21%] [added: 25%] | | | | | | [removed: 19%] [added: 21%] | | | | | | [removed: 17%] [added: 19%] | | |

Our sales and marketing efforts are focused on customer acquisition and retention to meet [removed: the] user, clinician, and payor demands for our Omnipod products.

We have streamlined and standardized our training [added: to support customer success and cost-effective onboarding] by developing online resources and [added: have] increased our field clinician team to directly train new users.

We created [removed: an] [added: tailored] online training [removed: program] [added: programs] for Omnipod customers transitioning to Omnipod 5 [removed: or] [added: and new] Omnipod [removed: DASH.][added: customers transitioning from MDI.]

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

to improve time-in-range (a dynamic measure of the percentage of time spent in glucose range) and reduce the occurrence of blood glucose highs and lows.

In 2026, we launched Omnipod Discover, a data analytics and reporting platform designed to give users, their caregivers, and health care providers actionable insights.

Omnipod Discover helps to identify trends and is intended to provide supplemental data to support diabetes management for Omnipod 5 users and to aid healthcare providers in patient care.

It also streamlines the process of starting on Omnipod products.

Consumers generally have coverage that pays for Omnipod products through commercial insurance plans or federal and state government healthcare programs, including Medicare and Medicaid.

We enter contracts establishing reimbursement for Omnipod products with national and third-party payors and government agencies that provide reimbursement in all 50 states.

Medicare Part D Plan Sponsors may provide coverage for Omnipod products under the Medicare Part D prescription drug program, which requires negotiating with third-party payors in order to provide our product through the pharmacy channel.

We also compete with companies in the insulin pump market, which today consists of tubed pump companies, in addition to companies that are working to develop and market new insulin “patch” pumps and other methods for the treatment of insulin-dependent diabetes.

We are also aware of the increasing use of GLP-1 products that may delay the progression of type 2 diabetes in obese patients.

- received 510(k) clearance for enhancements to the Omnipod 5 algorithm to include a lower target glucose set point.

In addition, we are working to integrate Omnipod 5 with Libre 3 Plus and developing Omnipod 6, our next-generation AID product.

In 2025, we completed STRIVE, our pivotal study for the next generation hybrid closed loop system.

Further, we continue to develop a fully closed loop AID system for type 2 diabetes (“FCL (T2)”).

In 2025, we completed enrollment for EVOLUTION 2, our safety and feasibility study for FCL (T2) and we plan to start the U.S. investigational device exemption (“IDE”) pivotal study in 2026.

We produce our products at our two highly automated manufacturing facilities in Acton, Massachusetts and Johor, Malaysia.

Additionally, we are investing in a third manufacturing plant in Costa Rica to support our continued growth.

Raw Materials, Components, and Sub-Assemblies

Failure to disclose reportable payments could subject us to significant penalties.

In the United States, California, Colorado, and Texas have introduced AI laws although they are not effective yet.

Other countries have also regulated the use of AI.

*Working, Environmental and Manufacturing Practices*.

*Environmental Reporting*.

We have also secured the necessary regulatory approvals for all other markets in which we currently distribute Omnipod products.

In 2025, we added an employee gift matching element to Insulet for Good where Insulet contributes to causes our employees care about.

Employee donations to non-profit organizations are matched, and volunteer hours have an Insulet financial support mechanism to engage and amplify employee contributions.

We also offer LinkedIn Learning and tuition reimbursement to eligible employees.

Our benefits vary by country with a wide range of offerings including health and life insurance, paid time off, employee stock purchase plan, paid parental leave, business travel accident insurance, and employee assistance program.

We have high standards for workplace safety and are committed to the safety and well-being of our workforce.

The Pod can be controlled by an Insulet-provided

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

In the United States, consumers generally have commercial insurance, Medicare or Medicaid coverage that pays for the product.

In addition, our virtual training allows us to onboard new Omnipod customers transitioning from MDI in a cost-effective manner.

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

The competitive landscape in our industry continues to undergo significant change.

In addition to the established insulin pump competitors, several companies are

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

These companies are at various stages of development and the number of such companies often changes as they enter or exit the market.

- 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 Omnipod 5 integration with Dexcom’s G7 CGM in the United States;

- received CE mark approval under the MDR for the added compatibility of both Dexcom’s G7 CGM and Libre 2 Plus with Omnipod 5 for individuals aged two years and older with type 1 diabetes; and

and Netherlands.

In 2024, we completed the first round of our EVOLUTION feasibility trial in New Zealand to test potential enhancements to the Omnipod 5 algorithm in order to further drive simplicity of use.

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

We are in the process of analyzing the data and making modifications for the next round of study.

In order to manufacture sufficient volumes of our Pods at high quality while still achieving a cost-effective per unit production price, we have designed our Pods to be manufactured through automation.

We produce our products at our highly automated manufacturing facility in Acton, Massachusetts and, beginning in June 2024, also at our new highly automated manufacturing plant in Malaysia, which we constructed to support our international expansion strategy and further ensure product supply.

This contract manufacturing agreement expires in October 2025 and is subject to automatic renewal, unless canceled by either party under the terms of the contract.

We also continue to invest in supply chain efficiencies, including automation improvements at our suppliers and contract manufacturer.

Raw Materials

Despite measures taken to protect our intellectual property, unauthorized parties may attempt to copy aspects of our products or obtain and use information that we regard as proprietary.

- the basic architecture of our Omnipod products, including the pump and the Controller/PDM;

The IDE must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound.

Clinical trials for a significant risk device may begin once an IDE is approved by the FDA and the appropriate Institutional Review Board (“IRB”) at each clinical trial site.

If the product is deemed a “non-significant risk” device, IDE approval from the FDA would not be required, but the clinical trial would need to meet other requirements including IRB approval.

Since clearance of the first generation of our Omnipod product, we have been subject to FDA inspections of our facilities on multiple occasions.

- the referral of an individual;

Liability under the statute may be established without a person or entity having actual knowledge of the statute or specific intent to violate it.

Although there are statutory and regulatory exceptions protecting certain common business practices, and we have structured our arrangements with physicians and other providers to comply with these exceptions, these arrangements may not expressly meet the requirements for applicable exceptions from the Stark Law.

Our business practices could be subject to scrutiny and enforcement under the federal False Claims Act.

We believe that we are in compliance with such laws.

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.

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

Failure to disclose reportable payments could subject us to penalties and materially adversely impact our business and financial results.

As a result, our provider and training arrangements may ultimately be found not to be in compliance with applicable laws.

Because of the breadth of these

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.

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.

The information required by this Item is provided under “Legal Proceedings” in Note [removed: 18] [added: 16] 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: 2024] [added: 2025] | | |

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: 2024] [added: 2025] was approximately [removed: $14.1] [added: $22.1] billion.

The number of shares of common stock outstanding as of February [removed: 13, 2025] [added: 11, 2026] was [removed: 70,226,104.][added: 70,395,848.]

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: 2024.][added: 2025.]

| Item 1 | | | [removed: [Business](#i777829bdc5b24aee9c434bde8dd545a5_13)] [added: [Business](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_13)] | | | [removed: [3](#i777829bdc5b24aee9c434bde8dd545a5_13)] [added: [3](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_13)] | | |

| Item 1A | | | [Risk [removed: Factors](#i777829bdc5b24aee9c434bde8dd545a5_16)] [added: Factors](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_16)] | | | [removed: [15](#i777829bdc5b24aee9c434bde8dd545a5_16)] [added: [14](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_16)] | | |

| Item 1B | | | [Unresolved Staff [removed: Comments](#i777829bdc5b24aee9c434bde8dd545a5_19)] [added: Comments](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_19)] | | | [removed: [27](#i777829bdc5b24aee9c434bde8dd545a5_19)] [added: [25](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_19)] | | |

| Item 1C | | | [removed: [Cybersecurity](#i777829bdc5b24aee9c434bde8dd545a5_22)] [added: [Cybersecurity](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_22)] | | | [removed: [28](#i777829bdc5b24aee9c434bde8dd545a5_22)] [added: [25](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_22)] | | |

| Item 2 | | | [removed: [Properties](#i777829bdc5b24aee9c434bde8dd545a5_25)] [added: [Properties](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_25)] | | | [removed: [29](#i777829bdc5b24aee9c434bde8dd545a5_25)] [added: [27](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_25)] | | |

| Item 3 | | | [Legal [removed: Proceedings](#i777829bdc5b24aee9c434bde8dd545a5_28)] [added: Proceedings](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_28)] | | | [removed: [29](#i777829bdc5b24aee9c434bde8dd545a5_28)] [added: [27](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_28)] | | |

| Item 4 | | | [Mine Safety [removed: Disclosures](#i777829bdc5b24aee9c434bde8dd545a5_31)] [added: Disclosures](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_31)] | | | [removed: [29](#i777829bdc5b24aee9c434bde8dd545a5_31)] [added: [27](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_31)] | | |

| Item 5 | | | [Market for [removed: Registrant](#i777829bdc5b24aee9c434bde8dd545a5_37)’[s] [added: Registrant](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_37)’[s] Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#i777829bdc5b24aee9c434bde8dd545a5_37)] [added: Securities](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_37)] | | | [removed: [30](#i777829bdc5b24aee9c434bde8dd545a5_37)] [added: [28](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_37)] | | |

| Item 6 | | | [removed: [Reserved](#i777829bdc5b24aee9c434bde8dd545a5_40)] [added: [Reserved](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_40)] | | | [removed: [31](#i777829bdc5b24aee9c434bde8dd545a5_40)] [added: [29](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_40)] | | |

| Item 7 | | | [removed: [Management](#i777829bdc5b24aee9c434bde8dd545a5_43)’[s] [added: [Management](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_43)’[s] Discussion and Analysis of Financial Condition and Results of [removed: Operations](#i777829bdc5b24aee9c434bde8dd545a5_43)] [added: Operations](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_43)] | | | [removed: [32](#i777829bdc5b24aee9c434bde8dd545a5_43)] [added: [30](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_43)] | | |

| Item 7A | | | [Quantitative and Qualitative Disclosures About Market [removed: Risk](#i777829bdc5b24aee9c434bde8dd545a5_67)] [added: Risk](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_67)] | | | [removed: [40](#i777829bdc5b24aee9c434bde8dd545a5_67)] [added: [38](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_67)] | | |

| Item 8 | | | [Financial Statements and Supplementary [removed: Data](#i777829bdc5b24aee9c434bde8dd545a5_70)] [added: Data](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_70)] | | | [removed: [41](#i777829bdc5b24aee9c434bde8dd545a5_70)] [added: [39](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_70)] | | |

| Item 9 | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#i777829bdc5b24aee9c434bde8dd545a5_178)] [added: Disclosure](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_175)] | | | [removed: [76](#i777829bdc5b24aee9c434bde8dd545a5_178)] [added: [73](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_175)] | | |

| Item 9A | | | [Controls and [removed: Procedures](#i777829bdc5b24aee9c434bde8dd545a5_181)] [added: Procedures](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_178)] | | | [removed: [76](#i777829bdc5b24aee9c434bde8dd545a5_181)] [added: [73](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_178)] | | |

| Item 9B | | | [Other [removed: Information](#i777829bdc5b24aee9c434bde8dd545a5_184)] [added: Information](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_181)] | | | [removed: [77](#i777829bdc5b24aee9c434bde8dd545a5_184)] [added: [73](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_181)] | | |

| Item 10 | | | [Directors, Executive Officers and Corporate [removed: Governance](#i777829bdc5b24aee9c434bde8dd545a5_193)] [added: Governance](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_190)] | | | [removed: [77](#i777829bdc5b24aee9c434bde8dd545a5_193)] [added: [74](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_190)] | | |

| Item 11 | | | [Executive [removed: Compensation](#i777829bdc5b24aee9c434bde8dd545a5_196)] [added: Compensation](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_193)] | | | [removed: [77](#i777829bdc5b24aee9c434bde8dd545a5_196)] [added: [74](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_193)] | | |

| Item 12 | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#i777829bdc5b24aee9c434bde8dd545a5_199)] [added: Matters](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_196)] | | | [removed: [77](#i777829bdc5b24aee9c434bde8dd545a5_199)] [added: [74](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_196)] | | |

| Item 13 | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#i777829bdc5b24aee9c434bde8dd545a5_202)] [added: Independence](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_199)] | | | [removed: [77](#i777829bdc5b24aee9c434bde8dd545a5_202)] [added: [74](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_199)] | | |

| Item 14 | | | [Principal Accounting Fees and [removed: Services](#i777829bdc5b24aee9c434bde8dd545a5_205)] [added: Services](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_202)] | | | [removed: [77](#i777829bdc5b24aee9c434bde8dd545a5_205)] [added: [74](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_202)] | | |

| Item 15 | | | [Exhibits, Financial Statement [removed: Schedules](#i777829bdc5b24aee9c434bde8dd545a5_211)] [added: Schedules](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_208)] | | | [removed: [78](#i777829bdc5b24aee9c434bde8dd545a5_211)] [added: [75](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_208)] | | |

| Item 16 | | | [Form 10-K [removed: Summary](#i777829bdc5b24aee9c434bde8dd545a5_214)] [added: Summary](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_211)] | | | [removed: [82](#i777829bdc5b24aee9c434bde8dd545a5_214)] [added: [79](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_211)] | | |

| [PART I](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_10) | | | | | | | | |

| [PART II](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_187) | | | | | | | | |

| [PART II](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_187)I | | | | | | | | |

| [PART I](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_187)V | | | | | | | | |

| | | | [SIGNATURES](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_214) | | | [80](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_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) | | |

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

Our Board [removed: of Directors (“Board”)] oversees management’s processes for identifying and mitigating risks, including [added: from] cybersecurity [removed: risks,] [added: threats,] to help align our risk exposure to our strategic objectives.

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

The NGR Committee is updated [added: regularly] on cybersecurity matters from our [removed: Chief Information Security Officer (“CISO”)] [added: CISO] and members of the CISO’s [removed: team at least twice annually.][added: team.]

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

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

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

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

[removed: The] [added: Our] CTO [removed: supports the] [added: and] CISO [removed: in chairing] [added: co-chair] a quarterly Technology Risk Committee aimed at providing proper oversight and governance of the cybersecurity program, remediation of identified [removed: technology risks,] [added: cybersecurity threats,] and execution of [removed: the] [added: our] cybersecurity strategy.

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

We leverage the National Institute of Standards and Technology (“NIST”) Cybersecurity Framework [added: 2.0] to [removed: better] manage and respond to cybersecurity [removed: risks in protecting our infrastructure and sensitive data.][added: threats.]

Additionally, Insulet’s information security management system is ISO 27001 and 27701 [removed: certified.][added: certified and we hold ISO certifications specific to Cloud Computing and Health Informatics.]

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

We maintain a cybersecurity risk register, and cybersecurity team leaders [removed: hold] [added: meet] monthly [removed: meetings] to discuss and prioritize [removed: risks as well as the status of any] [added: cybersecurity threats, review risk assessments, and monitor progress on] remediation [removed: activity.][added: activities.]

[added: - *Insider Risk Detection.*] We [removed: have] [added: use] targeted [added: third-party] tools aimed at detecting insider [added: cybersecurity] threats and suspicious data movement.

[added: - *Cloud and Vulnerability Management.*] To enhance cloud and data security, we [added: work to] reduce [removed: the] [added: our potential] attack surface by establishing secure defaults, implementing least [removed: privilege,] [added: privilege access principles,] and [added: continuously] monitoring [removed: configurations continuously.][added: cloud and system configurations.]

As part of [added: our] vulnerability and overall security posture management, [removed: we have] a [removed: focused] cross-functional team [removed: that] meets regularly to [removed: address] [added: review and remediate] issues identified [removed: by] [added: through] security scans and security configuration [removed: checks to maintain hygiene of Insulet’s computing devices.][added: checks.]

[added: - *Testing and Audits.*] Regular penetration testing, incident response tabletop testing, and [added: independent] audits are performed by [removed: trusted] third-party [removed: security consultants.][added: cybersecurity consultants and our Internal Audit function.]

[removed: These] [added: The results of these assessments, including] final reports and gap analysis [removed: documents] [added: documentation,] are [added: reviewed by our cybersecurity team and] logged [removed: into] [added: in] our risk [removed: register] [added: register,] as appropriate.

[removed: Vendors] [added: - *Vendor Management.* New vendors] and key [added: business] partners are subject to [removed: Insulet’s Vendor Risk assessment process and subsequently monitored by] our [removed: threat intelligence capability, which tracks our key vendors and suppliers.][added: vendor risk assessment process.]

[added: - *Training and Culture.*] Training, awareness, and incorporating [removed: security] [added: cybersecurity] into [removed: Insulet’s] [added: our] culture is key to reducing risk around common threats such as phishing.

We also conduct phishing simulations to [removed: test] [added: evaluate the] effectiveness of our training program with the [removed: aim] [added: goal] of reducing the percentage of employees who click on suspicious emails.

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

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

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

[removed: Pursuant to] [added: Under] the CIRP, cybersecurity incidents are [added: initially] reviewed and rated by our [removed: CISO and his] [added: security operations] team.

[removed: Our] [added: In addition, our] internal Disclosure Committee [removed: will review] [added: reviews] any planned public disclosures or [added: regulatory] filings.

*Risk Management and Strategy*

Like other companies, we currently operate in an environment characterized by increasing global cybersecurity vulnerabilities and threats.

Our cybersecurity team assesses, monitors, and manages cybersecurity risk through a combination of technical, physical, and administrative controls.

These controls include the implementing of cybersecurity policies, procedures, and strategies designed to prevent cybersecurity incidents to the extent feasible and to enhance the resilience of our systems to minimize business impact should a cybersecurity incident occur.

- *Ongoing Cybersecurity Threat Monitoring.* Our cybersecurity operations centers operate across multiple time zones to support continuous monitoring, enabling timely detection, investigation, and response to cybersecurity threats.

- *External Threat Landscape Assessment.* Insulet employs multiple third-party threat intelligence services to monitor for cybersecurity threats and cybersecurity incidents.

In addition, we participate in a third-party healthcare industry cybersecurity threat intelligence data-sharing organization.

This ongoing effort helps to maintain the security hygiene of our computing devices and supports the resilience of our technology environment.

- *Operating Technology (“OT”) Visibility.* As a manufacturer of medical devices, the interconnectedness between our OT and other business critical information systems can present material cybersecurity risks.

To mitigate these risks, we implement network segmentation, access controls, and OT-specific monitoring capabilities.

Once engaged, these vendors are monitored by our third-party threat intelligence tools.

Where appropriate, we incorporate security and privacy provisions or contractual addenda to ensure vendors maintain standards consistent with our cybersecurity and data protection requirements to ensure vendors maintain standards consistent with applicable cybersecurity and data protection law as well as our requirements.

All employees are required to complete annual cybersecurity training, supplemented by frequent “nanolearning” modules.

These short, targeted trainings are designed to increase awareness of cybersecurity threats among our employees and equip employees with the knowledge and tools needed to recognize and respond appropriately to potential cybersecurity threats.

We have processes in place to systematically integrate cybersecurity into each phase of our product design and development process.

Omnipod 5 incorporates authentication, encryption, and cybersecurity protection to safeguard against unauthorized devices or individuals accessing its system.

Cybersecurity incidents are rated based on predefined severity levels and escalated to members of our cybersecurity incident response team (“CIRT”) based on the facts and circumstances of the incident.

Our CIRT consists of our Chief Information Security Officer (“CISO”), Chief Compliance Officer, Chief Privacy Officer, VP of Commercial Legal, and relevant members of our executive leadership team, including our General Counsel and CEO.

When appropriate, such incidents are also reported to the Board of Directors (“Board”) in accordance with our governance protocols.

Cybersecurity risks are included in the risk universe evaluated by the ERM function as it identifies and assesses the Company’s top enterprise risks on an annual basis.

The results of the annual ERM risk assessment are presented to our Board, with additional reporting during the year to the Nominating, Governance and Risk Committee (“NGR Committee”) of the Board.

*Governance*

While the Board reviews the Company’s cybersecurity program annually, the

Our CTO has more than 15 years of experience leading R&D and information technology departments at medical device and technology companies.

We manage cyber risk on a daily basis, as we face a multitude of threats ranging from 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, 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.

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

For the 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.

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.

- 24/7 cyber monitoring.

Our security operations center is located in multiple time zones to ensure around-the-clock coverage and timely threat detection and response.

- External Threat Landscape Assessment.

Our integrated privacy, legal, and security teams are continuously monitoring for any external threat that may impact our operations.

Third-party threat intelligence feeds are leveraged to monitor Insulet’s digital footprint and activity that may cause brand damage.

- Insider Risk Detection.

- Cloud and Vulnerability Management.

- Testing and Audits.

- Operating Technology (“OT”) Visibility.

As a manufacturer of medical devices, OT is a vital component of our business operations.

Interconnectedness between OT technology and other business critical information technology

infrastructure can create a material cyber risk.

Insult deploys segmentation and OT-specific monitoring capabilities to mitigate and monitor this risk.

- Vendor Management.

- Training and Culture.

We have an operational information security training program for all employees.

In addition to annual trainings, we require and monitor completion of frequent “nanolearning” targeted trainings.

These quick trainings provide constant reminders to our employees to be vigilant and give them the tools to recognize and protect against cyber threats.

Our Secure Software Development Lifecycle enforces application testing and continuous monitoring to identify security risks.

Omnipod 5 incorporates authentication, encryption, and cybersecurity protection to ensure only trusted devices and authorized people can access the system.

Notwithstanding the extensive approach we take to cybersecurity, we may not be successful in preventing or mitigating a cybersecurity incident that could have a material adverse effect on us.

A cybersecurity incident rated at predefined risk levels will be escalated to CTO, the Chief Compliance Officer, and the General Counsel and assessed for materiality and disclosure to the CEO and the Board.

CIRP provides the organizational and operational structure to respond to incidents that may affect the confidentiality, integrity or availability of our information systems.

We also own a 400,000 square foot facility in Malaysia, which houses [removed: our new] manufacturing [removed: facility] and office space.

As of December 31, [removed: 2024,] [added: 2025,] we leased [removed: a total of 11] [added: 12] facilities in [removed: 6] [added: 7] countries consisting of approximately [removed: 297,000] [added: 289,000] square feet of office, research and development, and warehousing space and other related facilities, primarily in North [removed: America, Asia] [added: America] and Europe.

Additional information regarding our leases is provided in Note [removed: 14] [added: 12] to the consolidated financial statements included in Item 8 of this Form 10-K.

As of February [removed: 13, 2025,] [added: 11, 2026,] there were [removed: 6] [added: 5] 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 [removed: Composite Index, the NASDAQ] Health Care [removed: Index,] [added: Index] and the S&P 500 Index for the five-year period beginning on December 31, [removed: 2019,] [added: 2020,] and ending on December 31, [removed: 2024,] [added: 2025,] assuming reinvestment of all dividends.

[removed: ][added: ]

| | | | [removed: 2019 | | |] 2020 | | | 2021 | | | 2022 | | | 2023 | | | 2024 | | | [added: 2025 | | |]

| NASDAQ Health Care | | | $ | 100 | | $ | [removed: 130] [added: 96] | | $ | [removed: 125] [added: 77] | | $ | [removed: 100] [added: 82] | | $ | [removed: 106] [added: 81] | | $ | [removed: 105] [added: 99] | |

| Insulet Corporation | | | $ | 100 | | $ | 104 | | $ | 115 | | $ | 85 | | $ | 102 | | $ | 111 | |

| S&P 500 | | | $ | 100 | | $ | 129 | | $ | 105 | | $ | 133 | | $ | 166 | | $ | 196 | |

We did not purchase any shares under our $125 million share repurchase program during the fourth quarter 2025.

None.

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

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

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

(1) Our common stock was added to S&P 500 Index in March 2023.

Our financial statements as of December 31, [removed: 2024] [added: 2025] and [removed: 2023] [added: 2024] and for each of the three years in the period ended December 31, [removed: 2024,] [added: 2025,] 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](#i777829bdc5b24aee9c434bde8dd545a5_73)] [added: Firm](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_73)] (PCAOB ID Number 248) | | | [removed: [42](#i777829bdc5b24aee9c434bde8dd545a5_73)] [added: [40](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_73)] | | |

| [removed: Consolidated] [added: [Consolidated] Balance [removed: Sheets] [added: Sheets](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_76)] as of December 31, [removed: 2024] [added: 2025] and [removed: 2023] [added: 2024] | | | [removed: [44](#i777829bdc5b24aee9c434bde8dd545a5_76)] [added: [42](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_76)] | | |

| [removed: Consolidated] [added: [Consolidated] Statements of [removed: Income] [added: Income](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_79)] for the Years ended December 31, [removed: 2024, 2023] [added: 2025, 2024] and [removed: 2022] [added: 2023] | | | [removed: [45](#i777829bdc5b24aee9c434bde8dd545a5_79)] [added: [43](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_79)] | | |

| [Consolidated Statements of Comprehensive [removed: I](#i777829bdc5b24aee9c434bde8dd545a5_82)ncome] [added: I](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_82)ncome] for the Years ended December 31, [removed: 2024, 2023] [added: 2025, 2024] and [removed: 2022] [added: 2023] | | | [removed: [46](#i777829bdc5b24aee9c434bde8dd545a5_82)] [added: [44](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_82)] | | |

| [Consolidated Statements of Stockholders’ Equity for the Years ended December [removed: 31,](#i777829bdc5b24aee9c434bde8dd545a5_85) 2024, 2023] [added: 31,](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_85) 2025, 2024] and [removed: 2022] [added: 2023] | | | [removed: [47](#i777829bdc5b24aee9c434bde8dd545a5_85)] [added: [45](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_85)] | | |

| [Consolidated Statements of Cash Flows for the Years ended December [removed: 31,](#i777829bdc5b24aee9c434bde8dd545a5_88) 2024, 2023] [added: 31,](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_88) 2025, 2024] and [removed: 2022] [added: 2023] | | | [removed: [48](#i777829bdc5b24aee9c434bde8dd545a5_88)] [added: [46](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_88)] | | |

| [Notes to Consolidated Financial [removed: Statements](#i777829bdc5b24aee9c434bde8dd545a5_91)] [added: Statements](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_91)] | | | [removed: [49](#i777829bdc5b24aee9c434bde8dd545a5_91)] [added: [47](#if0d8ad34797b40b9ab3cf8dd2f88f9b1_91)] | | |

Board of Directors and [removed: Shareholders][added: Stockholders]

We have audited the accompanying consolidated balance sheets of Insulet Corporation (a Delaware corporation) and subsidiaries (the “Company”) as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] and the related consolidated statements of income, comprehensive income, stockholders’ equity, and cash flows for each of the three years in the period ended December 31, [removed: 2024,] [added: 2025,] and the related notes and financial statement schedule included under Item 15(a) (collectively referred to as the “consolidated financial statements”).

We also have audited the Company’s internal control over financial reporting as of December 31, [removed: 2024,] [added: 2025,] 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, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2024] [added: 2025] in conformity with accounting principles generally accepted in the United States of America.

Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2024,] [added: 2025,] based on criteria established in the 2013 Internal Control—Integrated Framework issued by COSO.

As described further in [removed: Note] [added: note] 2 to the [added: consolidated] financial statements, the Company provides for certain rebates for sales of its product through intermediaries.

The Company estimates variable consideration related to rebates to [added: managed care organizations, including] pharmacy benefit [removed: managers] [added: managers, governmental payors, and third-party commercial payors, primarily] in the United States when determining the transaction price at the time of sale.

We identified the [removed: rebate estimate] [added: provision] for [removed: pharmacy benefit managers] [added: rebates] as a critical audit matter.

The principal consideration for our determination that the [removed: rebate estimate related to pharmacy benefit managers] [added: provision for rebates] is a critical audit matter [removed: was] [added: is] the high degree of auditor judgment in applying procedures to evaluate the significant estimation made by management.

Our audit procedures related to the [removed: rebate estimate] [added: provision for rebates] included the following, among [removed: others;][added: others.]

| (in millions, except share and per share data) | | | [added: 2025 | | | | | |] 2024 | | | | | | 2023 | | |

| Cash and cash equivalents | | | $ | [removed: 953.4] [added: 716.1] | | | | | $ | [removed: 704.2] [added: 953.4] | |

| Accounts receivable trade, net | | | [removed: 252.5] [added: 516.9] | | | | | | [removed: 240.2] [added: 252.5] | | |

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

| Inventories | | | [removed: 430.4] [added: 452.6] | | | | | | [removed: 402.6] [added: 430.4] | | |

| Prepaid expenses and other current assets | | | [removed: 142.0] [added: 228.3] | | | | | | [removed: 116.4] [added: 142.0] | | |

| Total current assets | | | [removed: 1,891.3] [added: 1,914.0] | | | | | | [removed: 1,582.9] [added: 1,891.3] | | |

| Property, plant and equipment, net | | | [removed: 723.1] [added: 819.5] | | | | | | [removed: 664.9] [added: 723.1] | | |

| Other intangible assets, net | | | [removed: 98.5] [added: 117.1] | | | | | | [removed: 98.7] [added: 98.5] | | |

| Goodwill | | | [removed: 51.5] [added: 51.6] | | | | | | [removed: 51.7] [added: 51.5] | | |

| Deferred tax assets | | | [removed: 141.8] [added: 82.4] | | | | | | [removed: $] [added: 141.8] | [removed: 1.8] | |

| Other assets (includes [removed: $10.2] [added: $1.0] and [removed: $31.3] [added: $10.1] at fair value) | | | [removed: 181.5] [added: 205.8] | | | | | | [removed: 188.2] [added: 181.5] | | |

| Total assets | | | $ | [removed: 3,087.7] [added: 3,190.4] | | | | | $ | [removed: 2,588.2] [added: 3,087.7] | |

| Accounts payable | | | $ | [removed: 19.8] [added: 75.0] | | | | | $ | [removed: 19.2] [added: 19.8] | |

| Accrued expenses and other current liabilities | | | [removed: 423.8] [added: 586.7] | | | | | | [removed: 373.7] [added: 423.9] | | |

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

| Current portion of long-term debt | | | [removed: 83.8] [added: 18.4] | | | | | | [removed: 49.4] [added: 83.8] | | |

| Total current liabilities | | | [removed: 528.4] [added: 680.1] | | | | | | [removed: 451.2] [added: 528.4] | | |

| Long-term debt, net | | | [removed: 1,296.1] [added: 930.8] | | | | | | [removed: 1,366.4] [added: 1,296.1] | | |

| Total liabilities | | | [removed: 1,876.1] [added: 1,675.2] | | | | | | [removed: 1,855.5] [added: 1,876.1] | | |

| Commitments and contingencies (Note [removed: 18)] [added: 16)] | | | | | | | | | | | |

| Common stock, $.001 par value, 100,000,000 authorized; [removed: 70,196,031] [added: 70,588,192] and [removed: 69,907,289] [added: 70,390,816 shares] issued and [removed: outstanding] [added: outstanding, respectively, at December 31, 2025; and 70,196,031 issued and outstanding, at December 31, 2024] | | | 0.1 | | | | | | 0.1 | | |

*Variable consideration – Provision for rebates*

Management's estimate is based on historical experience, sales, trends, levels of inventory in the distribution channel, and contractual terms.

February 18, 2026

| (in millions, except share and per share data) | | | 2025 | | | | | | 2024 | | |

| Other liabilities | | | 64.4 | | | | | | 51.7 | | |

| Treasury stock, at cost; 197,374 and — shares | | | (60.4) | | | | | | — | | |

| Deferred compensation | | | 0.8 | | | | | | — | | |

See notes to consolidated financial statements.

Amounts may not add due to rounding.

| Loss on extinguishment of debt | | | (123.9) | | | | | | — | | | | | | — | | |

| Diluted | | | 71,886 | | | | | | 73,891 | | | | | | 73,633 | | |

See notes to consolidated financial statements.

Amounts may not add or recalculate due to rounding.

See notes to consolidated financial statements.

Amounts may not add due to rounding.

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

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

| Net income | | | — | | | | | | — | | | | | | — | | | | | | 247.1 | | | | | | — | | | | | | — | | | | | | — | | | | | | 247.1 | | |

| Other comprehensive income, net of tax | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 25.7 | | | | | | — | | | | | | — | | | | | | 25.7 | | |

| Repurchase of common stock | | | (184) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (59.6) | | | | | | — | | | | | | (59.6) | | |

| Deferred compensation | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (0.9) | | | | | | 0.9 | | | | | | — | | |

| Rabbi trust distribution | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 0.1 | | | | | | (0.1) | | | | | | — | | |

| Settlement of capped call options | | | — | | | | | | — | | | | | | 164.6 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 164.6 | | |

| Balance, December 31, 2025 | | | 70,391 | | | | | | $ | 0.1 | | | | | $ | 1,274.9 | | | | | $ | 287.4 | | | | | $ | 12.5 | | | | | $ | (60.4) | | | | | $ | 0.8 | | | | | $ | 1,515.2 | |

See notes to consolidated financial statements.

Amounts may not add due to rounding.

| Loss on extinguishment of debt | | | 123.9 | | | | | | — | | | | | | — | | |

| Gain on derivative asset | | | (12.5) | | | | | | — | | | | | | — | | |

| Other | | | (3.2) | | | | | | — | | | | | | (3.0) | | |

| Proceeds from issuance of senior unsecured notes, net of issuance costs | | | 440.7 | | | | | | — | | | | | | — | | |

| Settlement of capped call options | | | 164.6 | | | | | | — | | | | | | — | | |

| Repurchase of common stock | | | (59.6) | | | | | | — | | | | | | — | | |

See notes to consolidated financial statements.

Amounts may not add due to rounding.

Amounts have been calculated using actual, non-rounded figures; accordingly, amounts may not recalculate, and columns and rows within tables may not add due to rounding.

The amount of net realized and unrealized losses from foreign currency transactions for the year ended December 31, 2023 was insignificant.

Amortization expense is recorded in the same income statement line as the associated cloud operating expenses.

Provisions for chargebacks are reflected as deductions to accounts receivable.

The accruals for these fees are reflected as deductions to accounts receivable.

The provision for returns is reflected as a deduction to accounts receivable.

*Variable consideration – Rebates to pharmacy benefit managers*

Management's estimate is based on historical experience adjusted for revenue growth, trends, and contract amendments.

February 20, 2025

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

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

| | | | As of December 31, | | | | | | | | |

| Other liabilities | | | 51.6 | | | | | | 37.9 | | |

The accompanying notes are an integral part of these consolidated financial statements.

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

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

| Diluted | | | 73,890 | | | | | | 73,633 | | | | | | 69,910 | | |

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

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

| Balance, December 31, 2021 | | | 69,179 | | | | | | $ | 0.1 | | | | | $ | 1,207.9 | | | | | $ | (649.5) | | | | | $ | (2.2) | | | | | $ | 556.3 | |

| Adoption of ASU 202-06 (Note 2) | | | — | | | | | | — | | | | | | (207.7) | | | | | | 60.6 | | | | | | — | | | | | | (147.1) | | |

| Acquisition of a business | | | — | | | | | | (3.0) | | | | | | (26.0) | | |

Since the Company continues to introduce new products and versions, the anticipated performance of the product over the warranty period is also considered in estimating warranty reserves.

*•Discounts.* The Company provides customers with prompt payment discounts, which may result in adjustments to the price that is invoiced for the product transferred, in the case that payments are made within a defined period.

For the majority of this product line, revenue is recognized, with an associated unbilled receivable, as the product is produced pursuant to the customer’s firm purchase commitments.

The Company recognizes revenue over time using a blend of costs incurred to date relative to total estimated costs at completion and time incurred to date relative to total production time to measure progress toward the satisfaction of its performance obligations.

The Company believes that both incurred cost and elapsed time reflect the value generated, which best depicts the transfer of control to the customer.

Contract costs include third-party costs as well as an allocation of manufacturing overhead.

*Convertible Debt—*Effective January 1, 2022, the Company adopted ASU 2020-06, *Debt – Debt With Conversion and Other Options* *(Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity* using the modified retrospective method for convertible debt instruments outstanding as of the date of adoption.

Under ASU 2020-06, a convertible debt instrument is generally reported as a single liability at its amortized cost with no separate accounting for embedded conversion features.

Consequently, the effective interest rate of convertible debt instruments is closer to the coupon interest rate under this guidance.

The cumulative effect of adopting ASU 2020-06 resulted in a $207.7 million decrease to the opening balance of additional paid-in-capital upon adoption resulting from the derecognition of the embedded conversion feature and debt issuance costs bifurcated to equity, a $60.6 million decrease to the opening balance of accumulated deficit representing the cumulative interest expense recognized related to the amortization of the bifurcated conversion option and debt issuance costs, and a $147.1 million increase in long-term debt resulting from the derecognition of the discount associated with the embedded conversion feature, offset by the remaining debt issuance costs reclassified out of equity.

In addition, the Company wrote-off the related deferred tax liabilities with a corresponding adjustment to the valuation allowance, resulting in no net impact to the cumulative adjustment recorded to accumulated deficit.

Adoption of this standard had no impact on the Company’s diluted earnings per share as the Company historically calculated earnings per share using the if-converted method.

*Reference Rate Reform—*ASU 2020-04, *Reference Rate Reform (Topic 848) – Facilitation of the Effects of Reference Rate Reform on Reporting* and ASU 2021-01, *Reference Rate Reform (Topic 848) – Scope* allow companies to elect optional expedients and exceptions for applying U.S. GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform (e.g., discontinuation of the London Interbank Offered Rate (“LIBOR”)) if certain criteria are met.

During the fourth quarter of 2022, the Company elected to apply optional expedients for contract modifications to all eligible debt instruments and hedging relationships affected by the transition from LIBOR to the Secured Overnight Financing Rate (“SOFR”).

Accordingly, the Company did not have to assess whether the contract modification should be accounted for as a debt extinguishment.

Additionally, the Company was not required to de-designate hedging relationships when the contractual terms changed.

The adoption of these standards had no impact on our consolidated financial statements.

The following table presents selected financial information for the Company’s single operating segment, including significant expenses:

| Materials(1) | | | 296.7 | | | | | | 261.3 | | | | | | 198.0 | | |

| Factory conversion(2) | | | 176.9 | | | | | | 151.2 | | | | | | 125.7 | | |

| Depreciation and amortization(3) | | | 25.9 | | | | | | 26.3 | | | | | | 21.9 | | |

| Other costs of revenue(4) | | | 126.4 | | | | | | 98.4 | | | | | | 154.1 | | |

| Cost of revenue | | | 625.9 | | | | | | 537.2 | | | | | | 499.7 | | |

| Labor(5) | | | 478.4 | | | | | | 398.4 | | | | | | 343.7 | | |

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: 2024.][added: 2025.]

Based on the evaluation of our disclosure controls and procedures as of December 31, [removed: 2024,] [added: 2025,] our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at a reasonable assurance level.

Our management assessed the effectiveness of our internal control over financial reporting as of December 31, [removed: 2024.][added: 2025.]

Based on our assessment, we believe that our internal controls over financial reporting were effective as of December 31, [removed: 2024.][added: 2025.]

The effectiveness of our internal control over financial reporting as of December 31, [removed: 2024] [added: 2025] has been audited by Grant Thornton LLP, an independent registered public accounting firm.

[removed: Other than the actions taken to remediate the material weakness described above, there] [added: There] were no changes in our internal control over financial reporting during the three months ended December 31, [removed: 2024] [added: 2025] that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

*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.

Automated and manual business process controls that are dependent on the affected ITGCs were also deemed ineffective because they could have been adversely affected to the extent that they rely upon information and configurations from the affected systems.

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

We obtained and evaluated a service auditor’s report on the ITGCs over a system used by an outsourced service provider outside of North America.

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.

[removed: *Rule] [added: *(b) Rule] 10b5-1 Plans*

During the fourth quarter of [removed: 2024,] [added: 2025,] no [removed: other] director [removed: and none of our] [added: or] executive [removed: officers] [added: officer] 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.

*(a) Compensatory Arrangements of Certain Officers*

Approval of revised forms of Equity Agreements. On February 12, 2026, the Talent and Compensation Committee (the “Committee”) of our Board granted equity to executive officers pursuant to revised forms of Non-Qualified Stock Option Agreements (the “Stock Option Agreement”), Restricted Stock Unit Agreements (the “RSU Agreement”) and Performance Stock Unit Agreements (the “PSU Agreement”) for fiscal 2026 (the Stock Option Agreement, the RSU Agreement, and the PSU Agreement, collectively the “Equity Agreements”).

The Equity Agreements reflect a clarification to the definition of “for Cause” termination, expand eligibility for prorated vesting on retirement if certain age and service requirements are met, augment the language relating to compensation recoupment, extend the option exercise period for certain terminations “without Cause”, and make additional clarifying language changes, as set forth in the agreements.

The above description of the Stock Option Agreement, the RSU Agreement, and the PSU Agreement do not purport to be complete and are qualified in their entirety by reference to the agreements attached to this report as Exhibit 10.23, 10.24, and 10.25, respectively, and incorporated herein by reference.

On December 3, 2024, Wayne A. I. Frederick, a member of our Board of Directors, adopted a written trading plan intended to satisfy Rule 10b5-1(c) under the Exchange Act to sell up to 1,825 shares of our common stock between March 5, 2025 and December 31, 2025.

The trading plan will terminate upon the earlier of December 31, 2025, or the sale of all shares subject to the trading plan.

The information required by this Item will be set forth in our definitive proxy statement for our [removed: 2025] [added: 2026] 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: 2024.][added: 2025.]

(1) Includes our [added: 2025,] 2017 [removed: Plan] and [removed: our] 2007 [removed: Plan.][added: plans.]

As of December 31, [removed: 2024, 629,518] [added: 2025, 599,596] 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: $155.65.][added: $207.66.]

For more information relating to our equity compensation plans, see Note [removed: 19] [added: 17] to our consolidated financial statements.

(2) The shares available for future issuance are under our [removed: 2017] [added: 2025] Plan, which includes shares related to awards outstanding under the [added: 2017 and] 2007 [removed: Plan] [added: plans] that are terminated by expiration, [removed: forfeiture] [added: forfeiture,] or cancellation.

| Equity compensation plans approved by security holders(1) | | | 292,421 | | | | | | $ | 207.66 | | | | | 7,276,489 | | | (2) | | |

| Total | | | 292,421 | | | | | | $ | 207.66 | | | | | 7,276,489 | | | | | |

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

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

| 10.9* | | | [Form of [removed: Non-Executive Employee Incentive Stock Option Agreement under the] Insulet Corporation [removed: Third Amended and Restated 2007] [added: 2017] Stock Option and Incentive Plan [added: Non-Qualified Stock Option Agreement] (Incorporated by reference to Exhibit [removed: 10.60] [added: 10.1] to our [removed: Annual] [added: Current] Report on Form [removed: 10-K for the fiscal year ended December 31, 2015,] [added: 8-K,] filed February [removed: 29, 2016)](https://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1060_20151231x10k.htm)] [added: 22, 2023)](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000011/podd-2023x02x22ex101.htm)] | | |

| [removed: 10.10*] [added: 10.43+] | | | [removed: [Form of Section 16 Officer Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option] [added: [Supply Agreement, dated November 21, 2013, between Amgen] and [removed: Incentive Plan] [added: Insulet Corporation, as amended by Amendment No. 1 through Amendment No. 14] (Incorporated by reference to Exhibit [removed: 10.62] [added: 10.18] to our Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2015,] [added: 2016,] filed February [removed: 29, 2016)](https://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1062_20151231x10k.htm)] [added: 28, 2017)](https://www.sec.gov/Archives/edgar/data/1145197/000114519717000005/podd-exx1018_20161231x10k.htm)] | | |

| [removed: 10.11*] [added: 10.67++] | | | [removed: [Form of Vice President Incentive Stock Option Agreement under] [added: [Amendment, dated November 30, 2019, to] the [added: Purchase Agreement dated October 12, 2017 by and between] Insulet Corporation [removed: Third Amended] and [removed: Restated 2007 Stock Option and Incentive Plan] [added: NXP USA, Inc] (Incorporated by reference to Exhibit 10.64 to our Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2015,] [added: 2023,] filed February [removed: 29, 2016)](https://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1064_20151231x10k.htm)] [added: 23, 2024).](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000011/podd-exx1064_20231231x10k.htm)] | | |

| [removed: 10.12*] [added: 10.56++] | | | [removed: [Form of Incentive Stock Option] [added: [Data] Agreement [removed: under the] [added: by and between] Insulet Corporation [removed: Third Amended] and [removed: Restated 2007 Stock Option and Incentive Plan] [added: DexCom, Inc, dated May 7, 2020] (Incorporated by reference to Exhibit 10.4 to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, [removed: 2015,] [added: 2022,] filed August [removed: 12, 2015)](https://www.sec.gov/Archives/edgar/data/1145197/000114519715000059/podd-ex104_20150630x10q.htm)] [added: 5, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx104_2022x06x30x10q.htm)] | | |

| [removed: 10.13*] [added: 10.26*] | | | [removed: [Form of Incentive Stock Option Agreement under the Second Amended] [added: [Amended] and Restated [removed: 2007 Stock Option and] [added: Annual] Incentive [removed: Plan - 2015 Sales] [added: Compensation] Plan (Incorporated by reference to Exhibit [removed: 10.51] [added: 10.1] to our [removed: Annual] [added: Current] Report on Form [removed: 10-K for the fiscal year ended December 31, 2014,] [added: 8-K,] filed [removed: February 26, 2015)](https://www.sec.gov/Archives/edgar/data/1145197/000114519715000020/poddex1051_2014311210k.htm)] [added: December 17, 2025)](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000077/podd-2025x12x17ex101.htm)] | | |

| [removed: 10.14*] [added: 10.19*] | | | [Form of [removed: Non-Qualified Stock Option Agreement for Company Employees under the Second Amended and Restated 2007] [added: Insulet Corporation 2025] Stock Option and Incentive Plan [removed: (Incorporated] [added: Non-Qualified Stock Option Agreement](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000030/podd-2025x5x22ex101.htm) [(Incorporated] by reference to Exhibit [removed: 10.4] [added: 10.1] to our [removed: Quarterly] [added: Current] Report on Form [removed: 10-Q for the fiscal quarter ended September 30, 2014,] [added: 8-K,] filed [removed: November 5, 2014)](https://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex104_20140930x10q.htm)] [added: May 28, 2025)](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000030/podd-2025x5x22ex101.htm)] | | |

| [removed: 10.15*] [added: 10.22*] | | | [Form of [removed: Non-Qualified Stock Option Agreement for Non-Employee Directors under the Second Amended and Restated 2007] [added: Insulet Corporation 2025] Stock Option and Incentive Plan [removed: (Incorporated] [added: Restricted Stock Unit Agreement for Non-Employee Directors](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000030/podd-2025x5x22ex104.htm) [](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000030/podd-2025x5x22ex104.htm)[(Incorporated] by reference to Exhibit [removed: 10.5 to] [added: 10.](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000030/podd-2025x5x22ex104.htm)[4](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000030/podd-2025x5x22ex104.htm) [to] our [removed: Quarterly] [added: Current] Report on Form [removed: 10-Q for the fiscal quarter ended September 30, 2014,] [added: 8-K,] filed [removed: November 5, 2014)](https://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex105_20140930x10q.htm)] [added: May 28, 2025)](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000030/podd-2025x5x22ex104.htm)] | | |

| 10.16* | | | [Form of [removed: Incentive Stock Option Agreement under the Second Amended and Restated 2007] [added: Insulet Corporation 2017] Stock Option and Incentive Plan [added: Restricted Stock Unit Agreement] (Incorporated by reference to Exhibit [removed: 10.7] [added: 10.2] to our [removed: Quarterly] [added: Current] Report on Form [removed: 10-Q for the fiscal quarter ended September 30, 2014, filed November 5, 2014)](https://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex107_20140930x10q.htm)] [added: 8-K, filed](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000008/podd-2024x2x17ex102.htm) [February 20,](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000008/podd-2024x2x17ex102.htm) [2025](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000008/podd-2024x2x17ex102.htm)[)](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000008/podd-2024x2x17ex102.htm)] | | |

| 10.17* | | | [Form of [removed: Incentive Stock Option Agreement for Section 16 Officers under the Second Amended and Restated 2007] [added: Insulet Corporation 2017] Stock Option and Incentive Plan [added: Performance Stock Unit Agreement] (Incorporated by reference to Exhibit [removed: 10.10] [added: 10.3] to our [removed: Quarterly] [added: Current] Report on Form [removed: 10-Q for the fiscal quarter ended September 30, 2014, filed November 5, 2014)](https://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex1010_20140930x10q.htm)] [added: 8-K, filed](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000008/podd-2024x2x17ex103.htm) [February 20, 2025](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000008/podd-2024x2x17ex103.htm)[)](https://www.sec.gov/Archives/edgar/data/1145197/000114519725000008/podd-2024x2x17ex103.htm)] | | |

| [removed: 10.18*] [added: 10.12*] | | | [Form of [removed: Non-Qualified Stock Option Agreement for Section 16 Officers under the Second Amended and Restated 2007] [added: Insulet Corporation 2017] Stock Option and Incentive Plan [added: Non-Qualified Stock Option Agreement] (Incorporated by reference to Exhibit [removed: 10.11] [added: 10.1] to our [removed: Quarterly] [added: Current] Report on Form [removed: 10-Q for the fiscal quarter ended September 30, 2014,] [added: 8-K,] filed [removed: November 5, 2014)](https://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex1011_20140930x10q.htm)] [added: March 1, 2024)](https://www.sec.gov/Archives/edgar/data/1145197/000114519724000013/podd-2024x02x29ex101.htm)] | | |