Insulet (PODD) 10-K risk factor changes: FY2023 vs FY2022

We currently rely on sales of [removed: the Omnipod System, and tailored versions of the Omnipod System in] our [removed: Drug Delivery] [added: Omnipod] product [removed: line,] [added: platform] to generate nearly all our revenue.

[removed: Our main product is the Omnipod System, from which we] [added: We] expect to continue to derive nearly all our [removed: revenue.][added: revenue from our Omnipod product platform.]

Accordingly, our ability to continue to generate revenue is highly reliant on our ability to market and sell [removed: the] [added: our] Omnipod [removed: System] [added: products] and to retain consumers who currently use the product.

Our sales of [removed: the] Omnipod [removed: System] [added: products] may be negatively impacted by many factors, including:

- failure of [removed: the] [added: our] Omnipod [removed: System] [added: 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;

- reductions in reimbursement rates or coverage policies relating to [removed: the] Omnipod [removed: System] [added: products] by third-party payors;

- claims that any portion of [removed: the] Omnipod [removed: System] [added: products] infringes on intellectual property rights of others;

- adverse regulatory or legal actions relating to [removed: the] [added: our] Omnipod [removed: System;][added: products;]

- attrition rates of consumers who cease using [removed: the] Omnipod [removed: System;][added: products;]

- competitive pricing; [added: and]

- results of clinical studies relating to [removed: the] Omnipod [removed: System] [added: products] or our competitors’ [removed: products; and][added: products.]

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

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

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

If we [removed: fail] [added: are not able] to [removed: do so,] [added: successfully develop] our [added: 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 [added: our] product sales.

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

If we do not effectively manage our rapid growth, our business resources may become strained and we may not be able to deliver [removed: the Omnipod System] [added: our products] in a timely manner, which could [removed: harm] [added: adversely affect] our results of operations.

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

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

For example, we [removed: are currently working to implement] [added: recently implemented] a new enterprise resource planning system and [removed: significantly] [added: plan to] upgrade our customer relationship management system.

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

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

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

[added: In] the [added: United States, we currently have contracts establishing reimbursement for] Omnipod [removed: System] [added: products] with national and regional third-party payors and government agencies that provide reimbursement in all 50 states.

Medicare Part D Plan Sponsors may provide coverage for [removed: the] Omnipod [removed: System] [added: 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 in the United States.

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

Healthcare market initiatives in the United States may also lead third-party payors to decline or reduce reimbursement for [removed: the] Omnipod [removed: System.][added: products.]

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

As we expand our [removed: Omnipod System] sales and marketing efforts internationally, we face additional risks associated with obtaining and maintaining reimbursement from foreign healthcare payment systems on a timely basis or at all.

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

If an existing or future competitor develops a product that competes with or is superior to [removed: the] [added: our] Omnipod [removed: System,] [added: products,] our revenue may decline.

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

Technological breakthroughs in diabetes monitoring, treatment, or prevention could render [removed: the] [added: our] Omnipod [removed: System obsolete.][added: products obsolete or less desirable.]

[removed: The] [added: Our] Omnipod [removed: System is] [added: products are] based on our proprietary technology, but a number of companies, medical researchers, and pharmaceutical companies are pursuing new delivery devices, delivery technologies, sensing technologies, procedures, drugs, and other therapeutics for the monitoring, treatment, and/or prevention of insulin-dependent diabetes.

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

Future market or clinical studies may be unfavorable to [removed: the] [added: our] Omnipod [removed: System] [added: products] and [removed: its] [added: their] efficacy, which could hinder our sales efforts and have a material adverse effect on our business, results of operations, financial condition, and cash flows.

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

The data obtained from the studies may be unfavorable to [removed: the Omnipod System] [added: our products] or may be inadequate to support satisfactory conclusions.

In addition, in the future we may sponsor clinical trials to assess certain aspects of the efficacy of [removed: the Omnipod System.][added: our products.]

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

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

improved upon as our business needs change.

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

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

In addition, even the perception that new products may be introduced, or that technological or treatment advancements could occur, could cause consumers to delay the purchase of our products or impact our stock price.

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

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

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

We have been involved in patent infringement suits in the past and may be again in the future.

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

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

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

Continued concerns about the systemic impact of potential long-term and wide-spread recession and geopolitical issues, including wars and terrorism, have contributed to increased market volatility and diminished expectations for economic growth in the world.

Our business and results of operations may be adversely impacted by changes in macroeconomic conditions, including inflation, bank failures, rising interest rates and availability of capital markets.

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

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

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

Obtaining such regulatory clearance can be expensive and lengthy.

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

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

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

At least fifteen states have adopted new privacy laws in the past few years.

The California laws have served as a model for many subsequently adopted laws in other states.

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

For example, the GDPR imposes requirements in the European Economic Area relating to, among other things, consent to process personal

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

Any future significant compromise or breach of our data security, whether external or internal, or

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

The issuance of common stock in connection with the conversion of our Convertible Senior Notes, or the consummation of other equity transactions could limit our ability to utilize net operating loss and tax credit carryforwards to offset future U.S. federal and state taxes payable.

Additionally, during the second half of 2023 we introduced a new organizational operating model, which initially may be disruptive or confusing to some employees as job and reporting structures evolve, causing dissatisfaction or resulting in departures.

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

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

We believe this negatively impacted the stock prices of companies in the medical device industry, including ours.

We have identified control deficiencies that have been determined to be a material weakness in our internal control over financial reporting. This issue, if not remediated, could result in material misstatements in our financial statements and cause us to fail to meet our reporting and financial obligations.

As disclosed in Item 9A, “Controls and Procedures,” we have reported a material weakness because we did not maintain effective information technology general controls over systems that support our financial reporting outside of North America.

The material weakness will not be considered remediated until the enhanced controls operate for a sufficient period of time and management has concluded, through testing, that the related controls are effective.

We cannot assure that the measures we take will remediate the material weakness or that additional material weaknesses will not arise in the future.

Any failure to remediate the material weakness, or the development of new material weaknesses in our internal control over financial reporting, could result in material misstatements in our financial statements and cause us to fail to meet our reporting and financial obligations, which in turn could have a negative impact on our financial condition, results of operations or cash flows, restrict our ability to access the capital markets, require significant resources to correct the material weaknesses or deficiencies, subject us to fines, penalties or judgments, harm our reputation or otherwise cause a decline in investor confidence and cause a decline in the market price of our stock.

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

- development of an effective patch pump by one or more competitors.

We cannot assure you that we will be able to successfully develop our relationships with third-party intermediaries.

We have developed retention programs aimed at both healthcare professionals and consumers, which include appeals assistance, ongoing customer communications, newsletters, support, training, and an automatic re-order program for certain customers.

We have had a satisfactory customer retention rate; however, we cannot assure you that we will maintain this retention rate in the future.

In the United States, we currently have contracts establishing reimbursement for

If these competitors’ products were to gain acceptance by healthcare

For example, in 2020 Tandem launched an AID system, with which Omnipod 5 competes directly, and which could negatively impact our business.

Any technological breakthroughs in diabetes monitoring, treatment, or prevention could render the Omnipod System obsolete, which would have a material adverse effect on our business, financial condition, and results of operations.

measures to protect our intellectual property rights.

We also cannot ensure that patents issued to, or licensed by or to, us in the past or in the future will not be challenged or circumvented by competitors.

These patents may be found to be invalid or not sufficiently broad to preclude our competitors from introducing technologies similar to those covered by our patents and patent applications.

In addition, our ability to enforce and protect our intellectual property rights internationally may be limited in certain circumstances.

For example, we may not be able to protect our intellectual property rights effectively in China, where we rely on a third-party contract manufacturer to produce our product.

Our efforts to safeguard our unpatented and unregistered intellectual property rights, including requiring employees, consultants, and other third parties to sign confidentiality, non-disclosure, or assignment of invention agreements, may not be successful.

The agreements may be breached and trade secrets and other proprietary information could be disclosed to our competitors.

Further, we may have inadequate remedies for any breach.

In addition, others may independently develop substantially equivalent or superior proprietary information and techniques or gain access to our trade secrets or disclose such technologies.

While not a part of our business plans or operations, we have been involved in patent infringement suits in the past, including as disclosed in Note 17 to the consolidated financial statements included in Item 8.

glucose levels.

Our financial condition and results of operations have been and may to continue to be adversely affected by the COVID-19 pandemic and worldwide economic issues, such as inflation.

The COVID-19 pandemic and preventative measures taken to contain or mitigate the outbreak have caused, and to some degree are continuing to cause, business slowdown or shutdown in affected areas, supply chain disruptions, labor shortages, inflation and disruption in the financial markets globally.

Although China, where we manufacture a significant portion of our product, has experienced a recovery and we are currently producing at pre-COVID-19 levels, further disruption in China could hinder our ability to produce product and have a material adverse effect on our business and results of operations.

In addition, in January 2020, the U.K. withdrew from the European Union, commonly referred to as “Brexit”.

While the UK and the European Union entered into a Trade and Cooperation Agreement, a number of areas are still unsettled, and it is

possible that there could be greater restrictions on imports and exports and on the movement of people between the U.K. and European Union countries as well as increased regulatory complexities.

- demand for non-insulin drugs, including the impact of generics and biosimilars;

While we have received 510(k) clearance for our Omnipod Insulin Management System as well as modified versions of this device, including Omnipod DASH and Omnipod 5, we may be required to obtain a new 510(k) clearance or PMA for significant further post-market modifications.

Obtaining 510(k) clearance or PMA can be expensive and lengthy, and we may not be able to obtain them in a timely fashion or at all.

As part of this effort, the FDA is reviewing the adverse event reporting and recall processes for insulin pumps.

If our or our contract manufacturers’ facilities fails a quality system inspection, the manufacturing or distribution of our devices could be interrupted, and our operations disrupted.

Failure to take adequate and timely corrective action in response to an adverse quality system inspection could force a suspension or shutdown of our labeling operations or the manufacturing operations of our contract manufacturer, or a recall of our devices.

Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA.

In addition, the FDA could take enforcement action for failing to report the recalls when they were conducted.

letter, injunction, seizure, civil fine, or criminal penalties.

If we were found to be noncompliant with state DME licensure rules, we could lose our licensure in that state, which could prohibit us from selling our current or future products directly to consumers in that state.

Several states require that DME providers be licensed in order to sell products to customers in that state.

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

Although we believe we are in compliance with all applicable state regulations regarding licensure requirements, if we were found to be noncompliant, we could lose our licensure in that state, which could prohibit us from selling our current or future products directly to consumers in that state.

Colorado and Virginia have enacted similar privacy laws that will also take effect in 2023.

require notification to data subjects, including customers and others, when there is a security breach of personal data.

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

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

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

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

[removed: In addition, substantially] [added: Substantially] all of our Drug Delivery revenue consists of sales of pods to Amgen for use in the Neulasta® Onpro® kit, a delivery system for Amgen’s Neulasta to help reduce the risk of infection after intense chemotherapy.

We [removed: recently received CE Mark approval under the European MDR, and we] are [removed: currently focused] [added: working] on further building our international teams and advancing our regulatory, reimbursement, and market development [removed: efforts.][added: efforts so we can bring Omnipod 5 to additional international markets.]

[removed: In 2022,] [added: Additionally, in December 2023,] we completed [added: enrollment for] our [removed: Omnipod 5 type 2 diabetes feasibility study and plan to begin a] pivotal trial [removed: in 2023] [added: for Omnipod 5] with the goal of expanding Omnipod 5’s indication to type 2 users.

We also continue to expand market access and awareness of Omnipod [added: 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.

[removed: As we continue our growth in] [added: Subsequent to] the [removed: pharmacy channel,] [added: launch of Omnipod 5,] we [removed: plan] [added: began] to phase-out our Classic Omnipod in the U.S. in 2023, since the vast majority of our [added: U.S.] customer base is no longer using this product.

We [removed: have] also [removed: been taking] [added: continue to take] steps to [removed: continue strengthening] [added: strengthen] our global manufacturing capabilities.

[removed: Further, in 2022 we broke ground on] [added: We recently completed construction of] a new manufacturing plant in Malaysia to support our international expansion strategy, further ensure product supply, and drive higher gross margins over time.

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

The discussion of our results of operations for [removed: 2020] [added: 2021] 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: 2021] [added: 2022] filed with the Securities and Exchange Commission on February 24, [removed: 2022.][added: 2023.]

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

We recently achieved a milestone of [removed: 360,000] [added: approximately 425,000] estimated [added: active] global customers using [removed: Omnipod,] [added: Omnipod products,] including [removed: over 100,000 U.S.] [added: approximately 250,000 global] customers using [removed: the] Omnipod 5.

As we grow our customer base, we expect to generate an increasing portion of our revenues through recurring sales of our disposable Pods, which [removed: provides] [added: provide] recurring revenue.

Our [removed: recurring revenue business model, alongside the Omnipod System’s] [added: product’s] unique patented design [removed: enables] [added: allows] us to provide [removed: pump] [added: Pod] therapy at a [added: relatively] low or no up-front investment in regions where reimbursement allows for [removed: it.][added: it and our pay-as-you-go]

[removed: Our pay-as-you-go] pricing model [removed: also] reduces the risk to third-party payors.

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

We [removed: have also experienced and expect to] continue to experience challenges stemming from the global supply chain [removed: disruption that began during the coronavirus pandemic (“COVID-19”);] [added: disruption;] however, [added: while there is no guarantee of future performance,] to date we have been able to successfully mitigate this disruption and ensure uninterrupted supply to our customers by increasing our inventory levels and taking other measures.

While our mitigation efforts and inflation have and are expected to continue to negatively impact gross margins and net income in [removed: 2023,] [added: 2024,] we intend to continue to work to improve productivity to help offset these costs.

Comparison of the Years Ended December 31, [removed: 2022] [added: 2023] and December 31, [removed: 2021][added: 2022]

| [removed: (In] [added: (in] millions) | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | % Change | | | | | | Currency Impact | | | | | | Constant Currency(1) | | |

| Drug Delivery | | | [removed: 57.5] [added: 36.0] | | | | | | [removed: 87.4] [added: 57.5] | | | | | | [removed: (34.2)] [added: (37.4)] | | % | | | | — | | % | | | | [removed: (34.2)] [added: (37.4)] | | % |

Total revenue for [removed: 2022] [added: 2023] increased [removed: $206.5] [added: $391.8] million, or [removed: 18.8%,] [added: 30.0%,] to [removed: $1,305.3] [added: $1,697.1] million, compared with [removed: $1,098.8] [added: $1,305.3] million in [removed: 2021.][added: 2022.]

Constant currency revenue growth of [removed: 22.2%] [added: 29.6%] was primarily driven by higher volume and, to a lesser extent, favorable sales channel [removed: mix.][added: mix, partially offset by decreased drug delivery revenue.]

[removed: *U.S. Omnipod*][added: *U.S.*]

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

[removed: U.S.] [added: Revenue from the sale of] Omnipod [removed: revenue for 2022] [added: products in the U.S.] includes [removed: $249.9] [added: $473.7] million of related party [removed: revenue,] [added: revenue in 2023,] compared with [removed: $58.2] [added: $249.9] million in [removed: 2021.][added: 2022.]

The [removed: $191.7] [added: $223.8] million increase primarily resulted from [removed: a shift in certain revenues from one distributor to another as we worked to extend our reach] [added: growth] through the pharmacy channel.

In [removed: 2023,] [added: 2024,] we expect strong [removed: Omnipod] [added: U.S.] revenue growth driven by continued volume growth of Omnipod [removed: 5 in the pharmacy channel,] [added: 5,] continued [removed: adoption] [added: sales] of Omnipod DASH, and the benefits of our recurring revenue [removed: model.][added: model and pharmacy channel access.]

[removed: *International Omnipod*][added: *International*]

In [removed: 2023,] [added: 2024,] we expect higher International [removed: Omnipod] revenue due to continued volume growth driven by [added: new customers and conversions to Omnipod 5 in] the [added: U.K. and Germany and to a lesser extent, the] ongoing adoption of Omnipod [removed: DASH, partially offset by competition from AID systems and an unfavorable impact of currency exchange.][added: DASH.]

Drug Delivery revenue for [removed: 2022] [added: 2023] decreased [removed: $29.9] [added: $21.5] million, or [removed: 34.2%,] [added: 37.4%,] to [removed: $57.5] [added: $36.0] million, compared with [removed: $87.4] [added: $57.5] million in [removed: 2021.][added: 2022.]

In [removed: 2023,] [added: 2024,] we expect Drug Delivery revenue to decline [added: $18 million to $22 million] due to a lower [removed: demand] forecast from our partner.

| Cost of revenue | | | $ | [removed: 499.7] [added: 537.2] | | | | | [removed: 38.3] [added: 31.7] | | % | | | | $ | [removed: 346.7] [added: 499.7] | | | | | [removed: 31.6] [added: 38.3] | | % |

| Research and development expenses | | | $ | [removed: 180.2] [added: 205.0] | | | | | [removed: 13.8] [added: 12.1] | | % | | | | $ | [removed: 160.1] [added: 180.2] | | | | | [removed: 14.6] [added: 13.8] | | % |

| Selling, general and administrative expenses | | | $ | [removed: 587.8] [added: 734.9] | | | | | [removed: 45.0] [added: 43.3] | | % | | | | $ | [removed: 466.0] [added: 587.8] | | | | | [removed: 42.4] [added: 45.0] | | % |

Cost of revenue for [removed: 2022] [added: 2023] increased [removed: $153.0] [added: $37.5] million, or [removed: 44.1%,] [added: 7.5%,] to [removed: $499.7] [added: $537.2] million, compared with [removed: $346.7] [added: $499.7] million in [removed: 2021.][added: 2022.]

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

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

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

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

We have completed a randomized control trial in the U.S. and France for Omnipod 5 with DexCom’s G6 continuous glucose monitor (“CGM”) to support our pricing and market access initiatives.

In February 2024, we began our limited market release of Omnipod 5 with Dexcom’s G7 CGM in the United States and received CE mark approval for the added compatibility of Libre 2 Plus with Omnipod 5 for individuals aged two years and older with type 1 diabetes.

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

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

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

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

During the year ended December 31, 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. | | | $ | 1,251.0 | | | | | $ | 884.8 | | | | | 41.4 | | % | | | | — | | % | | | | 41.4 | | % |

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

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

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

Revenue from the sale of Omnipod products in the U.S. increased $366.2 million, or 41.4%, in 2023 to $1,251.0 million, compared with $884.8 million in 2022.

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

Revenue from the sale of Omnipod products in our international markets increased $47.1 million, or 13.0%, in 2023 to $410.1 million, compared with $363.0 million in 2022.

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

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

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

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

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

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

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

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

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

Research and development expenses as a percent of revenue declined to 12.1% in 2023, compared with 13.8% in 2022 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.

This increase was primarily attributable to year-over-year headcount additions, mainly to support international growth and costs associated with our new leadership structure that is designed to accelerate innovation and commercialization.

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

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

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

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

*Interest Expense and Income*

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

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

This increase was primarily driven by higher interest rates.

Other income 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.

Other expense of $1.1 million for 2022 consists primarily of net unrealized and realized foreign currency losses.

Accordingly, we have not reported any tax benefit relating to the remaining net operating loss carryforwards and income tax credit carryforwards that are available for utilization in future periods.

The Omnipod System features a small, lightweight, self-adhesive disposable tubeless Omnipod device that the user fills with insulin and wears directly on the body for up to three days at a time, which delivers personalized doses of insulin, and the PDM or Controller, a wireless handheld device that programs the Pod with the user’s personalized insulin-delivery instructions and wirelessly monitors the Pod’s operation.

To achieve this goal, our efforts have been focused on the launch of Omnipod 5, which in 2022 received FDA clearance for individuals aged two years and older with type 1 diabetes.

Our limited market release of Omnipod 5 in the United States began in the first quarter, and in the third quarter we launched our U.S. full market release.

We are also working to bring Omnipod 5 to our international markets.

We plan to launch Omnipod 5 in the U.K. and Germany in 2023 and to continue our international roll out more broadly in 2024.

Additionally, to accelerate our efforts to secure reimbursement for Omnipod 5, we have fully enrolled individuals in a randomized control trial in the U.S. and enrollment will begin soon in France.

Additionally, we continue to increase our presence within our existing markets and expand internationally in a targeted and strategic manner.

We opened an office in Dubai to serve as our primary local presence and regional infrastructure in the Middle East, launched Omnipod in Saudi Arabia, and expanded into the United Arab Emirates.

We are optimizing our operations in China by consolidating our production in that region into one location.

We have also developed a basal-only Pod for individuals with type 2 diabetes and submitted our 510(k) application to the FDA in November.

We expect commercialization of the basal-only Pod in 2024.

In addition to the estimated liability we recorded in 2022, we have a performance obligation to replace Omnipod DASH PDMs and Omnipod 5 Controllers sold subsequent to the MDC issuances, which is expected to negatively impact gross margins and net income in 2023, most notably in the first half of the year.

| U.S. Omnipod | | | $ | 884.8 | | | | | $ | 651.5 | | | | | 35.8 | | % | | | | — | | % | | | | 35.8 | | % |

| International Omnipod | | | 363.0 | | | | | | 359.9 | | | | | | 0.9 | | % | | | | (11.2) | | % | | | | 12.1 | | % |

| Total Omnipod | | | 1,247.8 | | | | | | 1,011.4 | | | | | | 23.4 | | % | | | | (3.6) | | % | | | | 27.0 | | % |

| Total | | | $ | 1,305.3 | | | | | $ | 1,098.8 | | | | | 18.8 | | % | | | | (3.4) | | % | | | | 22.2 | | % |

U.S. Omnipod revenue for 2022 increased $233.3 million, or 35.8%, to $884.8 million, compared with $651.5 million in 2021.

Existing customer conversions to Omnipod 5 also contributed to the revenue increase as some users fill both their starter kit and their first month of refills simultaneously.

International Omnipod revenue for 2022 increased $3.1 million, or 0.9%, to $363.0 million, compared with $359.9 million in 2021.

Excluding the 11.2% unfavorable impact of currency exchange, the remaining 12.1% increase was primarily due to higher volumes as we continue to expand awareness and access to Omnipod DASH, partially offset by increased competition from AID systems.

This decrease was primarily driven by a decline in production volume due to lower demand from our partner.

| | | | 2022 | | | | | | | | | | | | 2021 | | | | | | | | |

The 6.7 point decrease in gross margin was primarily driven by a $57.9 million net charge, or 4.5 points, associated with the voluntary MDCs we issued in 2022.

These decreases were partially offset by higher average selling price due to growth in the pharmacy channel, where Pods have a higher average selling price due in part to the fact that we offer the PDM/Controller for no charge.

We anticipate gross margin to increase due to significant costs associated with the MDCs in 2022, most of which we do not expect to recur in 2023 and higher volume in the pharmacy channel and favorable geographical sales mix.

We believe these increases will be partially offset by continued higher production costs as we further scale U.S. manufacturing, unfavorable product line mix due to higher costs associated with Omnipod 5 production, and higher costs as we contend with inflation.

This increase was primarily attributable to year-over-year headcount additions, mainly to support information technology and commercial operations and $25.2 million of legal charges related to the settlement of a patent infringement lawsuit, associated legal fees, and the settlement of a contract dispute.

To a lesser extent, these increases were due to an increase in investments to expand market acceptance and access to Omnipod, higher travel and entertainment expenses due to increased activity as COVID-19 restrictions have lifted, an increase in software license fees driven by investments in new systems to support our growing business and headcount additions, and higher amortization of cloud computing implementation costs.

These increases were partially offset by a decrease in direct-to-consumer advertising resulting from the timing of spend.

resource planning system.

Interest expense, net for 2022 decreased $34.5 million, or 56.4%, to $26.7 million, compared with $61.2 million in 2021.

This decrease was primarily driven by the adoption of Accounting Standards Update 2020-06, *Accounting for Convertible Debt Instruments and Contracts in an Entity's Own Equity* (“ASU 2020-06”), which eliminated most of the non-cash interest expense associated with our convertible notes.

*Loss on Extinguishment of Debt*

During 2021, we incurred a $42.4 million loss on extinguishment of debt related to the repurchase and conversion of all of our outstanding 1.375% Notes.

Other expense, net for 2022 decreased $0.8 million to $1.1 million, compared with $1.9 million in 2021.

The decrease was primarily driven by an increase in unrealized foreign currency gains, which was partially offset by realized foreign currency losses.

| Interest expense, net | | | 26.7 | | | | | | 61.2 | | |

| Voluntary MDCs(1) | | | 57.9 | | | | | | — | | |

| Loss on extinguishment of debt(4) | | | — | | | | | | 42.4 | | |

(1) Represents net charge recorded for the estimated costs associated with the voluntary MDCs.

At December 31, [removed: 2022,] [added: 2023,] no amounts were outstanding under our Revolving Credit Facility.

A 100 basis point increase or decrease in interest rates as of December 31, [removed: 2022] [added: 2023] would decrease or increase our annual earnings, respectively, by approximately $0.1 million.

As of December 31, [removed: 2022,] [added: 2023,] we had outstanding debt related to our convertible senior notes recorded on our consolidated balance sheet of [removed: $788.8] [added: $791.8] million, net of unamortized discount and issuance costs totaling [removed: $11.2] [added: $8.2] million.

The fair value of the convertible senior notes, which was [removed: $1,038.7] [added: $765.6] million as of December 31, [removed: 2022,] [added: 2023,] is also impacted by changes in our stock price.

[added: 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) in the event that at the time of conversion our stock price exceeds the conversion price under the 0.375% Notes.

Approximately [removed: 28%] [added: 24%] of our revenue was denominated in foreign currencies for the year ended December 31, [removed: 2022.][added: 2023.]

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

We have intercompany receivables and payables from our foreign subsidiaries that are denominated in foreign currencies, principally the Euro, the British [removed: pound] [added: pound, Mexican peso, Malaysian ringgit] and the Canadian dollar.

[removed: Net realized and unrealized gains (losses) from] foreign currency transactions are included in other [removed: (expense) income,] [added: income (expense),] net in the consolidated statement of operations and amounted to a loss of [removed: $1.3] [added: $0.4] million for the year ended December 31, [removed: 2022.][added: 2023.]

Net realized and unrealized gains (losses) from

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

We expect the Capped Calls to reduce the potential dilution to our common stock

Insulet Corporation (“we” or the “Company”) is primarily engaged in the development, manufacture and sale of its proprietary [removed: Omnipod® System, a] continuous insulin delivery [removed: system] [added: systems] for people with insulin-dependent [removed: diabetes, which we have been selling since 2005.][added: diabetes.]

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

[removed: In addition, substantially all of our Drug Delivery revenue consists of sales of] [added: We also produce] pods [removed: to] [added: for] Amgen for use in the Neulasta® Onpro® kit, a delivery system for Amgen’s Neulasta to help reduce the risk of infection after intense chemotherapy.

Initially, many people with type 2 diabetes attempt to manage their diabetes with improvements in diet, exercise, and/or [added: medications, both] oral [removed: medications.][added: and injectable, including SGLT2 inhibitors and GLP-1 drugs.]

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

We believe these factors present a significant available market for [removed: the] [added: our] Omnipod [removed: System] [added: platform] globally.

People with insulin-dependent diabetes need a continuous supply of insulin, known as basal insulin, [removed: to provide] for background metabolic needs.

[removed: In addition] to [removed: basal insulin, people with insulin-dependent diabetes 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.

There are two primary types of insulin therapy practiced today: multiple daily [removed: injections] [added: injection] (“MDI”) therapy using syringes or insulin pens and pump therapy using insulin pumps.

MDI therapy involves [removed: the administration of] [added: injecting] fast-acting insulin before meals (bolus) to lower blood glucose levels to a healthy range.

Our Solution: The Omnipod [removed: System][added: Platform]

The Omnipod [removed: System is a] [added: platform offers] continuous insulin delivery [removed: system] that provides all the benefits of insulin pump therapy in a unique [removed: way.][added: way without the need for external tubing required with conventional pumps.]

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

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

The [removed: Pod] [added: 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 back, and] delivers insulin into the body through a small flexible tube (called a [removed: cannula); and][added: cannula).]

[removed: Additionally, Omnipod 5 is interoperable] [added: The Pod integrates] with a third-party continuous glucose monitor (“CGM”) [removed: sold separately that obtains] [added: to obtain] glucose values [removed: and integrates with the Pod.][added: through wireless Bluetooth communication.]

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

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

In the U.S., the PDM has [removed: nightly] [added: Wi-Fi capabilities to enable] automatic data uploads providing users and their clinicians with cloud access to [removed: data,] [added: data] and enhancements for pushing software updates wirelessly to users.

The Pod can be worn for up to three days at a time and, because it is waterproof [added: (with an IP28 rating for] up to 25 [removed: feet,] [added: feet for 60 minutes),] there is no need to remove it when showering, swimming, or performing other activities.

Omnipod 5, which builds on our Omnipod DASH platform, [added: described below,] was cleared by the [removed: U.S. Food and Drug Administration (“FDA”)] [added: FDA] in January 2022.

In September 2022, we received CE Mark approval for Omnipod 5 under the European Union Medical Device Regulation [removed: (“MDR”).][added: (“MDR”) and in 2023, we launched Omnipod 5 in the United Kingdom and Germany.]

Omnipod 5 includes [removed: an] [added: a proprietary] AID algorithm [removed: that is located on] [added: embedded in] the Pod.

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

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

The Pod currently integrates with [removed: a CGM manufactured by] Dexcom, [removed: Inc.][added: Inc.’s G6 CGM and we recently launched a limited market release with Dexcom’s G7 CGM.]

[removed: Subsequent to] [added: Following] the launch of Omnipod 5, the vast majority of our customer base is no longer using our Classic Omnipod product.

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

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

[removed: The] Omnipod [removed: System is] [added: products are] currently available in the following [removed: 24] [added: 25] countries:

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

For the year ended December 31, [removed: 2022, 84%] [added: 2023, 90%] of [removed: our] Omnipod [removed: System] [added: product] sales [added: globally] were through intermediaries.

| | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | |

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

| Distributor [removed: B] [added: C] | | | [removed: 17%] [added: 19%] | | | | | | [removed: 12%] [added: 17%] | | | | | | [removed: 10%] [added: 12%] | | |

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

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

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

- Building consumer awareness about the features and benefits that [removed: the] Omnipod [removed: System provides] [added: products provide] to simplify diabetes management.

- Strengthening physician support by demonstrating clinical evidence of how [removed: the] Omnipod [removed: System improves] [added: products improve] outcomes and quality of life and providing data and insights to physicians offering diabetes care.

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

In addition to basal insulin, people with insulin-dependent diabetes require supplemental insulin, known as bolus insulin,

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

|  | | |  | | |  | | |

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

We expect to launch the iOS app in 2024.

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

connection if established.

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

Omnipod Classic

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

Omnipod GO

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

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

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

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

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

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

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

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

Data Management

See Item 1C.

“Cybersecurity” for additional information.

Our Omnipod platform’s unique patented

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

design allows us to provide Pod therapy at a relatively low or no up-front investment, which reduces the risk to third-party payors in the U.S.

In our international locations we sell either directly to consumers or through a distributor/intermediary.

In all countries where we operate either Insulet or our partners establish appropriate reimbursement contracts with healthcare systems in those countries and provinces.

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 access.

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

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

| Australia | | | Cyprus | | | Greece | | | Netherlands | | | Switzerland | | |

| Austria | | | Denmark | | | Iceland | | | Norway | | | Turkey | | |

| Belgium | | | Finland | | | Israel | | | Qatar | | | United Arab Emirates | | |

| Canada | | | France | | | Italy | | | Saudi Arabia | | | United Kingdom | | |

| Croatia | | | Germany | | | Kuwait | | | Sweden | | | United States | | |

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

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

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

Further, we recently launched a limited market release for Omnipod 5 integration with Dexcom’s G7 CGM in the United States.

As a result, many people have difficulty managing their diabetes.

|  | | |  | | |  | | |

The Omnipod System features two discreet and easy-to-use devices that eliminates the need for the external tubing required with conventional pumps:

- a small, lightweight, self-adhesive disposable tubeless Omnipod device (“Pod”) that the user fills with insulin and wears directly on the body.

It can be worn in multiple locations, including the abdomen, hip, back of upper arm, upper thigh, or lower back.

- the Personal Diabetes Manager (“PDM”) or Controller, a wireless, handheld device that programs the Pod with the user’s personalized insulin-delivery instructions and wirelessly monitors the Pod’s operation.

Omnipod DASH was fully launched in the United States in 2019 and in our international markets starting in 2020.

As a result, Omnipod DASH is easy to use, which reduces the training burden on healthcare professionals and users.

We believe that Omnipod DASH’s overall ease of use and flexibility make it very attractive to people with insulin-dependent diabetes and their healthcare professionals.

The Pod integrates with a third-party CGM to obtain glucose values trough wireless Bluetooth communication.

We plan to phase-out our Classic Omnipod product in the U.S. in 2023.

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

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

In addition, Insulet’s information security management system is International Organization for Standardization (“ISO”) 27001 and 27701 certified, which are the international standard for best practice in an information security management system globally.

Insulet continues to advance the cybersecurity capabilities of our medical devices.

Omnipod 5 is globally recognized for incorporating the highest standards for information and cyber security by design, which includes secure data transfer between the Pod and the Controller, as well as secure cloud storage.

Omnipod 5 is certified by ISO 27001 and the U.K. Cyber Essentials.

In addition, Omnipod 5 utilizes state-of-the-art authentication, encryption, and cybersecurity protection that enables the use of approved personal smartphone devices.

These entities, and the Company in some cases, seek reimbursement from health insurance companies and/or government administrative payors.

The Omnipod System’s unique patented design allows us to provide pump therapy at a relatively low or no up-front investment, which reduces the risk to third-party payors in the U.S. In certain international locations in which we sell through a distributor or intermediary, our distribution partners and local intermediaries establish appropriate reimbursement contracts with healthcare systems in those countries and provinces.

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

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

| Australia | | | Finland | | | Italy | | | Sweden | | |

| Austria | | | France | | | Kuwait | | | Switzerland | | |

| Belgium | | | Germany | | | Netherlands | | | Turkey | | |

| Canada | | | Greece | | | Norway | | | United Arab Emirates | | |

| Croatia | | | Iceland | | | Qatar | | | United Kingdom | | |

| Denmark | | | Israel | | | Saudi Arabia | | | United States | | |

The Omnipod System is also marketed to physicians.

| Distributor C | | | * | | | | | | 10% | | | | | | 11% | | |

majority share of the tubed insulin pump market.

Our non-insulin Drug Delivery product line competes with drug delivery device companies such as West Pharmaceutical Services, Inc.

In addition, we have a development and commercialization agreement to integrate Abbott Diabetes Care, Inc.’s CGM with Omnipod 5 in the future and are also working on developing an iOS app that could be utilized to control Omnipod 5 Pods.

Additionally, in November 2022, we submitted our 510(k) application to the FDA for a basal-only Pod for individuals with type 2 diabetes, which is a version of Omnipod specifically designed for customers on basal-only therapy.

The basal-only Pod is designed to deliver a fixed rate of rapid-acting insulin for 72 continuous hours and does not require a PDM/Controller or phone application for use.

We believe a key contributing factor to the overall attractiveness and success of the Omnipod System is the disposable nature of the Pod.

In 2019, we began producing product at our highly automated manufacturing facility in Acton, Massachusetts and in 2020 and 2021, we began producing on additional lines in this facility.

We have optimized our operations in China by consolidating our Omnipod production in that region into this one location.

In January 2022, we acquired one of our suppliers to bring key intellectual property and expertise in-house, strengthen our production capabilities and mitigate supply chain risks.

least dual sourced.

The information required by this Item is provided under “Legal Proceedings” in Note [removed: 17] [added: 19] 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: 2022] [added: 2023] | | |

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the [removed: Exchange] Act).

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: 2022] [added: 2023] was approximately [removed: $15.1] [added: $20.1] billion.

The number of shares of common stock outstanding as of February [removed: 16, 2023] [added: 15, 2024] was [removed: 69,542,257.][added: 69,925,730.]

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: 2022.][added: 2023.]

| Item 1 | | | [removed: [Business](#i0c69bee1b7c6495895ec2961d1c58cdb_13)] [added: [Business](#i5c5eb5e0e38c49dcae99416b1fdf5f72_13)] | | | [removed: [3](#i0c69bee1b7c6495895ec2961d1c58cdb_13)] [added: [3](#i5c5eb5e0e38c49dcae99416b1fdf5f72_13)] | | |

| Item 1A | | | [Risk [removed: Factors](#i0c69bee1b7c6495895ec2961d1c58cdb_16)] [added: Factors](#i5c5eb5e0e38c49dcae99416b1fdf5f72_16)] | | | [removed: [15](#i0c69bee1b7c6495895ec2961d1c58cdb_16)] [added: [15](#i5c5eb5e0e38c49dcae99416b1fdf5f72_16)] | | |

| Item 1B | | | [Unresolved Staff [removed: Comments](#i0c69bee1b7c6495895ec2961d1c58cdb_19)] [added: Comments](#i5c5eb5e0e38c49dcae99416b1fdf5f72_19)] | | | [removed: [29](#i0c69bee1b7c6495895ec2961d1c58cdb_19)] [added: [28](#i5c5eb5e0e38c49dcae99416b1fdf5f72_19)] | | |

| Item 2 | | | [removed: [Properties](#i0c69bee1b7c6495895ec2961d1c58cdb_22)] [added: [Properties](#i5c5eb5e0e38c49dcae99416b1fdf5f72_22)] | | | [removed: [29](#i0c69bee1b7c6495895ec2961d1c58cdb_22)] [added: [29](#i5c5eb5e0e38c49dcae99416b1fdf5f72_22)] | | |

| Item 3 | | | [Legal [removed: Proceedings](#i0c69bee1b7c6495895ec2961d1c58cdb_25)] [added: Proceedings](#i5c5eb5e0e38c49dcae99416b1fdf5f72_25)] | | | [removed: [29](#i0c69bee1b7c6495895ec2961d1c58cdb_25)] [added: [29](#i5c5eb5e0e38c49dcae99416b1fdf5f72_25)] | | |

| Item 4 | | | [Mine Safety [removed: Disclosures](#i0c69bee1b7c6495895ec2961d1c58cdb_28)] [added: Disclosures](#i5c5eb5e0e38c49dcae99416b1fdf5f72_28)] | | | [removed: [29](#i0c69bee1b7c6495895ec2961d1c58cdb_28)] [added: [29](#i5c5eb5e0e38c49dcae99416b1fdf5f72_28)] | | |

| Item 5 | | | [Market for [removed: Registrant](#i0c69bee1b7c6495895ec2961d1c58cdb_34)’[s] [added: Registrant](#i5c5eb5e0e38c49dcae99416b1fdf5f72_34)’[s] Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#i0c69bee1b7c6495895ec2961d1c58cdb_34)] [added: Securities](#i5c5eb5e0e38c49dcae99416b1fdf5f72_34)] | | | [removed: [30](#i0c69bee1b7c6495895ec2961d1c58cdb_34)] [added: [30](#i5c5eb5e0e38c49dcae99416b1fdf5f72_34)] | | |

| Item 6 | | | [removed: [Reserved](#i0c69bee1b7c6495895ec2961d1c58cdb_37)] [added: [Reserved](#i5c5eb5e0e38c49dcae99416b1fdf5f72_37)] | | | [removed: [31](#i0c69bee1b7c6495895ec2961d1c58cdb_37)] [added: [31](#i5c5eb5e0e38c49dcae99416b1fdf5f72_37)] | | |

| Item 7 | | | [removed: [Management](#i0c69bee1b7c6495895ec2961d1c58cdb_40)’[s] [added: [Management](#i5c5eb5e0e38c49dcae99416b1fdf5f72_40)’[s] Discussion and Analysis of Financial Condition and Results of [removed: Operations](#i0c69bee1b7c6495895ec2961d1c58cdb_40)] [added: Operations](#i5c5eb5e0e38c49dcae99416b1fdf5f72_40)] | | | [removed: [32](#i0c69bee1b7c6495895ec2961d1c58cdb_40)] [added: [32](#i5c5eb5e0e38c49dcae99416b1fdf5f72_40)] | | |

| Item 7A | | | [Quantitative and Qualitative Disclosures About Market [removed: Risk](#i0c69bee1b7c6495895ec2961d1c58cdb_61)] [added: Risk](#i5c5eb5e0e38c49dcae99416b1fdf5f72_61)] | | | [removed: [40](#i0c69bee1b7c6495895ec2961d1c58cdb_61)] [added: [41](#i5c5eb5e0e38c49dcae99416b1fdf5f72_61)] | | |

| Item 8 | | | [Financial Statements and Supplementary [removed: Data](#i0c69bee1b7c6495895ec2961d1c58cdb_64)] [added: Data](#i5c5eb5e0e38c49dcae99416b1fdf5f72_64)] | | | [removed: [41](#i0c69bee1b7c6495895ec2961d1c58cdb_64)] [added: [42](#i5c5eb5e0e38c49dcae99416b1fdf5f72_64)] | | |

| Item 9 | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#i0c69bee1b7c6495895ec2961d1c58cdb_166)] [added: Disclosure](#i5c5eb5e0e38c49dcae99416b1fdf5f72_169)] | | | [removed: [73](#i0c69bee1b7c6495895ec2961d1c58cdb_166)] [added: [77](#i5c5eb5e0e38c49dcae99416b1fdf5f72_169)] | | |

| Item 9A | | | [Controls and [removed: Procedures](#i0c69bee1b7c6495895ec2961d1c58cdb_169)] [added: Procedures](#i5c5eb5e0e38c49dcae99416b1fdf5f72_172)] | | | [removed: [73](#i0c69bee1b7c6495895ec2961d1c58cdb_169)] [added: [77](#i5c5eb5e0e38c49dcae99416b1fdf5f72_172)] | | |

| Item 9B | | | [Other [removed: Information](#i0c69bee1b7c6495895ec2961d1c58cdb_172)] [added: Information](#i5c5eb5e0e38c49dcae99416b1fdf5f72_175)] | | | [removed: [73](#i0c69bee1b7c6495895ec2961d1c58cdb_172)] [added: [81](#i5c5eb5e0e38c49dcae99416b1fdf5f72_175)] | | |

| Item 10 | | | [Directors, Executive Officers and Corporate [removed: Governance](#i0c69bee1b7c6495895ec2961d1c58cdb_178)] [added: Governance](#i5c5eb5e0e38c49dcae99416b1fdf5f72_181)] | | | [removed: [73](#i0c69bee1b7c6495895ec2961d1c58cdb_178)] [added: [81](#i5c5eb5e0e38c49dcae99416b1fdf5f72_181)] | | |

| Item 11 | | | [Executive [removed: Compensation](#i0c69bee1b7c6495895ec2961d1c58cdb_181)] [added: Compensation](#i5c5eb5e0e38c49dcae99416b1fdf5f72_184)] | | | [removed: [73](#i0c69bee1b7c6495895ec2961d1c58cdb_181)] [added: [81](#i5c5eb5e0e38c49dcae99416b1fdf5f72_184)] | | |

| Item 12 | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#i0c69bee1b7c6495895ec2961d1c58cdb_184)] [added: Matters](#i5c5eb5e0e38c49dcae99416b1fdf5f72_187)] | | | [removed: [74](#i0c69bee1b7c6495895ec2961d1c58cdb_184)] [added: [81](#i5c5eb5e0e38c49dcae99416b1fdf5f72_187)] | | |

| Item 13 | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#i0c69bee1b7c6495895ec2961d1c58cdb_187)] [added: Independence](#i5c5eb5e0e38c49dcae99416b1fdf5f72_190)] | | | [removed: [74](#i0c69bee1b7c6495895ec2961d1c58cdb_187)] [added: [81](#i5c5eb5e0e38c49dcae99416b1fdf5f72_190)] | | |

| Item 14 | | | [Principal Accounting Fees and [removed: Services](#i0c69bee1b7c6495895ec2961d1c58cdb_190)] [added: Services](#i5c5eb5e0e38c49dcae99416b1fdf5f72_193)] | | | [removed: [74](#i0c69bee1b7c6495895ec2961d1c58cdb_190)] [added: [81](#i5c5eb5e0e38c49dcae99416b1fdf5f72_193)] | | |

| Item 15 | | | [Exhibits, Financial Statement [removed: Schedules](#i0c69bee1b7c6495895ec2961d1c58cdb_196)] [added: Schedules](#i5c5eb5e0e38c49dcae99416b1fdf5f72_199)] | | | [removed: [75](#i0c69bee1b7c6495895ec2961d1c58cdb_196)] [added: [82](#i5c5eb5e0e38c49dcae99416b1fdf5f72_199)] | | |

| Item 16 | | | [Form 10-K [removed: Summary](#i0c69bee1b7c6495895ec2961d1c58cdb_199)] [added: Summary](#i5c5eb5e0e38c49dcae99416b1fdf5f72_202)] | | | [removed: [78](#i0c69bee1b7c6495895ec2961d1c58cdb_199)] [added: [86](#i5c5eb5e0e38c49dcae99416b1fdf5f72_202)] | | |

| | | | or | | | | | |

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).

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

| Item 1C | | | [Cybersecurity](#i5c5eb5e0e38c49dcae99416b1fdf5f72_1674) | | | [28](#i5c5eb5e0e38c49dcae99416b1fdf5f72_1674) | | |

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

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

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

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

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

| [PART I](#i0c69bee1b7c6495895ec2961d1c58cdb_10) | | | | | | | | |

| [PART II](#i0c69bee1b7c6495895ec2961d1c58cdb_175) | | | | | | | | |

| [PART II](#i0c69bee1b7c6495895ec2961d1c58cdb_175)I | | | | | | | | |

| [PART I](#i0c69bee1b7c6495895ec2961d1c58cdb_175)V | | | | | | | | |

| | | | [SIGNATURES](#i0c69bee1b7c6495895ec2961d1c58cdb_202) | | | [79](#i0c69bee1b7c6495895ec2961d1c58cdb_202) | | |

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

Accordingly, we have invested in resources (people, process, and technology) aimed at identifying, assessing, and responding to cyber threats.

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

While the Board reviews the Company’s cybersecurity program annually, the Nominating, Governance, and Risk Committee of the Board has primary responsibility for cybersecurity as part of its risk oversight mandate.

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

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

The Nominating, Governance, and Risk Committee Chair reports back to the full Board after each Committee meeting, including information relating to the cybersecurity discussions.

Our Cybersecurity organization, which includes corporate and product security, is led by our CISO.

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

Our CISO has over a decade of experience as a leader of cyber-security and technology risk management programs in both healthcare and medical device manufacturing organizations.

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

The CTO ensures cyber-security measures are prioritized across research and development, software engineering, and our IT functions.

Assessing, identifying and managing cybersecurity-related risks are also integrated into our overall enterprise risk management (“ERM”) process.

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

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

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

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

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

Additionally, Insulet’s information security management system is ISO 27001 and 27701 certified.

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

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

We maintain a cybersecurity risk register, and cybersecurity team leaders hold monthly meetings to discuss and prioritize risks as well as the status of any remediation activity.

Key facets of our cybersecurity program include:

- 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.

We have targeted tools aimed at detecting insider threats and suspicious data movement.

- Cloud and Vulnerability Management.

To enhance cloud and data security, we reduce the attack surface by establishing secure defaults, implementing least privilege, and monitoring configurations continuously.

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

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

- Testing and Audits.

Regular penetration testing, incident response tabletop testing, and audits are performed by trusted third-party security consultants.

These final reports and gap analysis documents are logged into our risk register as appropriate.

- Operating Technology (“OT”) Visibility.

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

As of December 31, [removed: 2022,] [added: 2023,] we leased a total of [removed: 22] [added: 13] facilities in [removed: 10] [added: 7] countries consisting of approximately [removed: 300,000] [added: 282,000] square feet of office, research and development, and warehousing space and other related facilities, primarily in North America, Asia and Europe.

In addition, we leased a 344,000 square foot facility in Malaysia under a finance lease arrangement, which houses our new manufacturing facility and office space.

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

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

As of February [removed: 16, 2023,] [added: 15, 2024,] there were [removed: 7] [added: 6] registered holders of record of our common stock.

The following graph shows the cumulative total return on $100 invested in each of our common stock, the NASDAQ Composite Index, [removed: and] the NASDAQ Health Care [added: Index, and the S&P 500] Index for the five-year period beginning on December 31, [removed: 2017,] [added: 2018,] and ending on December 31, [removed: 2022,] [added: 2023,] assuming reinvestment of all dividends.

[removed: ][added: ]

| | | | [removed: 2017 | | |] 2018 | | | 2019 | | | 2020 | | | 2021 | | | 2022 | | | [added: 2023 | | |]

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

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

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

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

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

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

| Insulet Corporation | | | $ | 100 | | $ | 115 | | $ | 248 | | $ | 370 | | $ | 386 | | $ | 427 | |

| NASDAQ Composite | | | $ | 100 | | $ | 96 | | $ | 130 | | $ | 187 | | $ | 227 | | $ | 152 | |

| NASDAQ Health Care | | | $ | 100 | | $ | 96 | | $ | 121 | | $ | 157 | | $ | 151 | | $ | 120 | |

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

Our financial statements as of December 31, [removed: 2022] [added: 2023] and [removed: 2021] [added: 2022] and for each of the three years in the period ended December 31, [removed: 2022,] [added: 2023,] 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](#i0c69bee1b7c6495895ec2961d1c58cdb_67)] [added: Firm](#i5c5eb5e0e38c49dcae99416b1fdf5f72_67)] (PCAOB ID Number 248) | | | [removed: [42](#i0c69bee1b7c6495895ec2961d1c58cdb_67)] [added: [43](#i5c5eb5e0e38c49dcae99416b1fdf5f72_67)] | | |

| Consolidated Balance Sheets as of December 31, [removed: 2022] [added: 2023] and [removed: 2021] [added: 2022] | | | [removed: [44](#i0c69bee1b7c6495895ec2961d1c58cdb_70)] [added: [45](#i5c5eb5e0e38c49dcae99416b1fdf5f72_70)] | | |

| Consolidated Statements of Operations for the Years ended December 31, [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020] [added: 2021] | | | [removed: [45](#i0c69bee1b7c6495895ec2961d1c58cdb_73)] [added: [46](#i5c5eb5e0e38c49dcae99416b1fdf5f72_73)] | | |

| [Consolidated Statements of Comprehensive [removed: I](#i0c69bee1b7c6495895ec2961d1c58cdb_76)ncome] [added: I](#i5c5eb5e0e38c49dcae99416b1fdf5f72_76)ncome] for the Years ended December 31, [removed: 2022, 2021] [added: 2023, 2022] and [removed: 2020] [added: 2021] | | | [removed: [46](#i0c69bee1b7c6495895ec2961d1c58cdb_76)] [added: [47](#i5c5eb5e0e38c49dcae99416b1fdf5f72_76)] | | |

| [Consolidated Statements of Stockholders’ Equity for the Years ended December [removed: 31,](#i0c69bee1b7c6495895ec2961d1c58cdb_79) 2022, 2021] [added: 31,](#i5c5eb5e0e38c49dcae99416b1fdf5f72_79) 2023, 2022] and [removed: 2020] [added: 2021] | | | [removed: [47](#i0c69bee1b7c6495895ec2961d1c58cdb_79)] [added: [48](#i5c5eb5e0e38c49dcae99416b1fdf5f72_79)] | | |

| [Consolidated Statements of Cash Flows for the Years ended December [removed: 31,](#i0c69bee1b7c6495895ec2961d1c58cdb_82) 2022, 2021] [added: 31,](#i5c5eb5e0e38c49dcae99416b1fdf5f72_82) 2023, 2022] and [removed: 2020] [added: 2021] | | | [removed: [48](#i0c69bee1b7c6495895ec2961d1c58cdb_82)] [added: [49](#i5c5eb5e0e38c49dcae99416b1fdf5f72_82)] | | |

| [Notes to Consolidated Financial [removed: Statements](#i0c69bee1b7c6495895ec2961d1c58cdb_85)] [added: Statements](#i5c5eb5e0e38c49dcae99416b1fdf5f72_85)] | | | [removed: [49](#i0c69bee1b7c6495895ec2961d1c58cdb_85)] [added: [50](#i5c5eb5e0e38c49dcae99416b1fdf5f72_85)] | | |

We have audited the accompanying consolidated balance sheets of Insulet Corporation (a Delaware corporation) and subsidiaries (the “Company”) as of December 31, [removed: 2022 and 2021,] [added: 2023] and [added: 2022,] the related consolidated statements of operations, comprehensive income, changes in stockholders’ equity, and cash flows for each of the three years in the period ended December 31, [removed: 2022,] [added: 2023,] and the related notes and financial statement schedule included under Item 15(a) (collectively referred to as the “financial statements”).

We also have [removed: audited] [added: audited, in accordance with] the [added: standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the] Company’s internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] based on criteria established in the 2013 [removed: *Internal Control—Integrated Framework*] [added: Internal Control—Integrated Framework] issued by the Committee of Sponsoring Organizations of the Treadway Commission [removed: (“COSO”).][added: (“COSO”), and our report dated February 22, 2024 expressed an adverse opinion.]

In our opinion, the financial statements [removed: referred to above] present fairly, in all material respects, the financial position of the Company as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2022] [added: 2023] in conformity with accounting principles generally accepted in the United States of America.

[removed: As discussed in Note 2 to the financial statements,] [added: *Convertible Debt—*Effective January 1, 2022,] the Company [removed: changed its method of accounting for convertible debt in 2022 due to the adoption of] [added: adopted] Accounting Standards Update [added: (“ASU”)] 2020-06, *Debt – Debt With Conversion and Other [removed: Options (Subtopic] [added: 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 [removed: Equity.*][added: Equity* using the modified retrospective method for convertible debt instruments outstanding as of the date of adoption.]

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

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

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

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

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

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

We identified the [removed: accounting] [added: rebate estimate] for [removed: the resolution of the contract dispute] [added: pharmacy benefit managers] as a critical audit matter.

Our audit procedures related to the [removed: contract dispute resolution] [added: rebate estimate] included the following, among [removed: others.][added: others;]

*Variable consideration – Rebates to [removed: Intermediaries*][added: pharmacy benefit managers*]

[removed: The Company estimates variable consideration related to rebates to pharmacy benefit managers] [added: Management's estimate is] based on historical experience adjusted for revenue growth, [added: trends, specific known] market [removed: trends and] events, [removed: individual agreements, product mix and,] [added: and] as [removed: available,] [added: available] channel inventory data.

Our audit procedures related to the [removed: rebate estimate] [added: realizability of the U.S. deferred tax assets] included the following, among others.

- We tested the design and operating effectiveness of controls related to management’s [removed: process to determine rebates, including the completeness and accuracy of the underlying data used in management’s estimation.][added: estimate.]

- [removed: We performed] [added: Performed] retrospective analysis comparing [removed: amounts invoiced] [added: actual rebates incurred] to [removed: and paid by] the [removed: Company to] previously estimated amounts.

| (in millions, except share and per share data) | | | [added: 2023 | | | | | |] 2022 | | | | | | 2021 | | |

| Cash and cash equivalents | | | $ | [removed: 674.7] [added: 704.2] | | | | | $ | [removed: 791.6] [added: 674.7] | |

| Accounts receivable trade, net | | | [removed: 140.9] [added: 240.2] | | | | | | [removed: 135.2] [added: 140.9] | | |

| Accounts receivable trade, net — related party | | | [removed: 64.7] [added: 119.5] | | | | | | [removed: 25.8] [added: 64.7] | | |

| Inventories | | | [removed: 346.8] [added: 402.6] | | | | | | [removed: 303.2] [added: 346.8] | | |

| Prepaid expenses and other current assets | | | [removed: 86.9] [added: 116.4] | | | | | | [removed: 74.0] [added: 86.9] | | |

| Total current assets | | | [removed: 1,314.0] [added: 1,582.9] | | | | | | [removed: 1,329.8] [added: 1,314.0] | | |

| Property, plant and equipment, net | | | [removed: 599.9] [added: 664.9] | | | | | | [removed: 536.5] [added: 599.9] | | |

| Other intangible assets, net | | | [removed: 75.5] [added: 98.7] | | | | | | [removed: 36.6] [added: 75.5] | | |

| Goodwill | | | 51.7 | | | | | | [removed: 39.8] [added: 51.7] | | |

| Other assets | | | [removed: 210.0] [added: 190.0] | | | | | | [removed: 106.1] [added: 210.0] | | |

| Total assets | | | $ | [removed: 2,251.1] [added: 2,588.2] | | | | | $ | [removed: 2,048.8] [added: 2,251.1] | |

| Accounts payable | | | $ | [removed: 30.8] [added: 19.2] | | | | | $ | [removed: 37.7] [added: 30.8] | |

| Accrued expenses and other current liabilities | | | [removed: 301.0] [added: 373.7] | | | | | | [removed: 164.3] [added: 301.0] | | |

| Accrued expenses and other current liabilities — related party | | | [removed: 5.4] [added: 8.9] | | | | | | [removed: 1.7] [added: 5.4] | | |

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

Opinion on the financial statements

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

The Company estimates variable consideration related to rebates to pharmacy benefit managers in the United States when determining the transaction price at the time of sale.

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

- Evaluated the significant assumptions and the completeness and accuracy of the underlying data used in management’s calculation through inspection of source documents and agreement to other audited schedules.

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

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

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

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

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

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

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

February 22, 2024

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

| (in millions, except share and per share data) | | | 2023 | | | | | | 2022 | | |

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

| Interest expense | | | (36.2) | | | | | | (36.0) | | | | | | (61.7) | | |

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

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

| Other comprehensive loss | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (12.0) | | | | | | (12.0) | | |

| Balance, December 31, 2023 | | | 69,907 | | | | | | $ | 0.1 | | | | | $ | 1,102.6 | | | | | $ | (378.0) | | | | | $ | 8.0 | | | | | $ | 732.7 | |

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

| Net income | | | $ | 206.3 | | | | | $ | 4.6 | | | | | $ | 16.8 | |

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

The net cash balance of the notional cash pooling arrangement is included within cash and cash equivalents in the consolidated balance sheets and was insignificant at both December 31, 2023 and 2022.

The Company also has investments in debt securities of privately held companies, which are either classified as available-for-sale securities or for which the Company has elected the fair value option.

The available-for-sale securities are recorded at fair value with unrealized gains and losses recorded as a component of accumulated other comprehensive income (loss) in stockholders’ equity on the consolidated balance sheet.

The other investment is a debt security that contains embedded derivatives.

Unrealized gains and losses for this investment are recorded as a component of other income (loss), net in the consolidated statement of operations.

All investments in debt securities are recorded within other assets on the consolidated balance sheet.

Judgement is involved in estimating inputs, such as discount rates, used in Level 3 fair value measurements.

Changes to these inputs can have a significant effect on fair value measurements and amounts that could be realized.

impairment.

Cloud computing arrangements includes services used to support certain internal corporate functions as well as technology platforms that support commercial initiatives.

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

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

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

The lease term used to calculate the right-of-use asset and related lease liability includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise the option.

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

| | | | | | |

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

Opinions on the financial statements and internal control over financial reporting

Also, in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2022, based on criteria established in the 2013 *Internal Control—Integrated Framework* issued by COSO.

Change in accounting principle

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

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

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

Definition and limitations of internal control over financial reporting

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

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

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

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

*Contract Dispute*

As described further in note 17 to the financial statements, the Company entered into an Asset Purchase Agreement as part of the resolution to an ongoing contract dispute.

Pursuant to this agreement the Company made a one-time payment of $25.0 million to the counterparty for the acquisition of developed technology, patents, and the release of future obligations.

This amount was allocated between the intangible assets acquired and the settlement component based on estimated fair values.

The principal considerations for our determination that the accounting for the resolution of the contract dispute is a critical audit matter are (1) applying the accounting guidance for allocating the consideration paid, which is complex and requires judgement and (2) estimating the allocation of the fair value of those elements.

These considerations heightened the complexity surrounding the design and execution of audit procedures to respond to this risk.

- We consulted with our national office resources regarding management’s accounting conclusion that the transaction consisted of multiple elements to be valued and that consideration paid should be allocated using estimated fair values.

- With the assistance of valuation professionals with specialized skills and knowledge, we tested management’s fair value of the identified intangible assets.

This included an assessment of the appropriateness of the methodology, inputs and key assumptions used, particularly the selection of the relief from royalty method to value the intangible assets, prospective financial information, royalty rates, the probability factor related to defending the patent asset and the selection of the discount rate.

We identified the rebate estimate as a critical audit matter.

The principal consideration for our determination that the rebate estimate is a critical audit matter is the level of judgement and complexity surrounding the design and execution of audit procedures to respond to this risk due to the subjectivity of the adjustments to historical experience based on recent product variation and volume.

- We tested the completeness and accuracy of inputs into the calculation as follows: inspected source documents on a sample basis to test historical rebates, compared revenue growth rates to other audited schedules, and performed sensitivity analyses on the subjective adjustments to historical experience.

February 23, 2023

| Interest expense, net | | | (26.7) | | | | | | (61.2) | | | | | | (45.1) | | |

| Balance, December 31, 2019 | | | 62,685 | | | | | | $ | 0.1 | | | | | $ | 749.0 | | | | | $ | (672.0) | | | | | $ | (1.2) | | | | | $ | 75.9 | |

| Adoption of ASU 2016-13 (Note 2) | | | — | | | | | | — | | | | | | — | | | | | | (1.1) | | | | | | — | | | | | | (1.1) | | |

| Issuance of common stock | | | 2,370 | | | | | | — | | | | | | 477.5 | | | | | | — | | | | | | — | | | | | | 477.5 | | |

| Other comprehensive income | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 6.7 | | | | | | 6.7 | | |

| Cash paid for marketable securities | | | — | | | | | | — | | | | | | (37.9) | | |

| Proceeds from mortgage, net of issuance costs | | | — | | | | | | — | | | | | | 68.3 | | |

| Proceeds from issuance of common stock, net | | | — | | | | | | — | | | | | | 477.5 | | |

Omnipod DASH features a secure Bluetooth enabled Pod and PDM with a color touch screen user interface supported by smartphone connectivity.

The Omnipod System is sold either directly to end-users or indirectly through intermediaries.

In 2022, the Company made strategic investments in two companies in the amount of $5.0 million and $2.8 million.

As of December 31, 2022 and 2021, there were no impairments or adjustments to the Company’s equity investments without readily determinable fair values.

Effective January 1, 2020, the Company adopted Accounting Standards Update (“ASU”) 2016-13, *Credit Losses (Topic 326)* (“ASU 2016-13”) using the modified retrospective method, whereby the guidance is applied prospectively as of the date of adoption and prior periods are not restated.

The cumulative effect of adopting ASU 2016-13 resulted in a $1.1 million increase to the opening balance of accumulated deficit upon adoption related to an increase in the allowance for credit losses on accounts receivable.

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: 2022.][added: 2023.]

Based on the evaluation of our disclosure controls and procedures as of December 31, [removed: 2022,] [added: 2023,] our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were [added: not] effective [removed: at a reasonable assurance level.][added: due to the material weakness identified and described below.]

There were no changes in our internal control over financial reporting during the three months ended December 31, [removed: 2022] [added: 2023] that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Our management assessed the effectiveness of our internal control over financial reporting as of December 31, [removed: 2022.][added: 2023.]

The effectiveness of our internal control over financial reporting as of December 31, [removed: 2022] [added: 2023] has been audited by Grant Thornton LLP, an independent registered public accounting firm.

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

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

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.

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

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

*Management’s Annual Report on Internal Control Over Financial Reporting*

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

Management is committed to remediating the deficiencies described above.

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

- ITGCs over the system used by an outsourced provider, and

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

Management believes that these actions will remediate the material weakness.

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

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

Board of Directors and Shareholders

Insulet Corporation

Opinion on internal control over financial reporting

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

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

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

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

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

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

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

Basis for opinion

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

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

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

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

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

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

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

Definition and limitations of internal control over financial reporting

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

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

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

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

Other information

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

/s/ GRANT THORNTON LLP

Based on our assessment, we believe that our internal controls over financial reporting were effective as of December 31, 2022.

*Rule 10b5-1 Plans*

On November 23, 2023, Prem Singh, the Company’s Senior Vice President, Global Operations, adopted a trading plan intended to satisfy Rule 10b5-1(c) under the Exchange Act to sell up to 775 shares of our common stock between February 23, 2024 and November 22, 2024, the date this plan expires.

The trading plan will cease upon the earlier of November 22, 2024 or the sale of all shares subject to the trading plan.

During the fourth quarter of 2023, none of our other executive officers and none of our directors 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.

None.

The information required by this Item will be set forth in our definitive proxy statement for our [removed: 2023] [added: 2024] 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: 2022.][added: 2023.]

| Equity compensation plans [added: not] approved by security [removed: holders(1)] [added: holders] | | | [removed: 695,588] [added: —] | | | | | | [removed: $] [added: —] | [removed: 109.73] | | | | | [removed: 2,709,488] [added: —] | | | [removed: (2)] | | |

| Equity compensation plans [removed: not] approved by security [removed: holders] [added: holders(1)] | | | [removed: —] [added: 436,094] | | | | | | $ | [removed: —] [added: 135.37] | | | | | [removed: —] [added: 2,524,732] | | | [added: (2)] | | |

As of December 31, [removed: 2022, 413,027] [added: 2023, 494,126] 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: $109.73.][added: $135.37.]

For more information relating to our equity compensation plans, see Note [removed: 18] [added: 20] to our consolidated financial statements.

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

| Total | | | 695,588 | | | | | | 109.73 | | | | | | 2,709,488 | | | | | |

| 3.2 | | | [removed: [Second](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000015/podd-2022x02x24ex31.htm) [Amended] [added: [Second Amended] and Restated By-laws of the Registrant (Incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K, filed [removed: February](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000015/podd-2022x02x24ex31.htm) [24, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000015/podd-2022x02x24ex31.htm)[](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000015/podd-2022x02x24ex31.htm)] [added: February 24, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000015/podd-2022x02x24ex31.htm)] | | |

| [removed: 10.4*] [added: 10.12*] | | | [Form of [added: Incentive Stock Option Agreement under the] Insulet Corporation [removed: 2017] [added: Third Amended and Restated 2007] Stock Option and Incentive Plan [removed: Restricted Stock Unit Agreement for Employees] (Incorporated by reference to Exhibit [removed: 10.6] [added: 10.4] to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, [removed: 2017,] [added: 2015,] filed August [removed: 4, 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000013/a2017planrsuformemployee_e.htm)] [added: 12, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000059/podd-ex104_20150630x10q.htm)] | | |

| [removed: 10.5*] [added: 10.17*] | | | [Form of [removed: Insulet Corporation 2017 Stock Option and] Incentive [removed: Plan Performance Vesting Restricted] Stock [removed: Unit] [added: Option] Agreement for [added: Section 16] Officers [added: under the Second Amended and Restated 2007 Stock Option and Incentive Plan] (Incorporated by reference to Exhibit [removed: 10.1] [added: 10.10] to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, [removed: 2017,] [added: 2014,] filed November [removed: 3, 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000017/podd-exx101_20170930x10q.htm)] [added: 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex1010_20140930x10q.htm)] | | |

| [removed: 10.6*] [added: 10.8*] | | | [Form of [removed: Insulet Corporation 2017 Stock Option and Incentive Plan] Non-Qualified Stock Option Agreement for [added: Non-Employee] Directors [added: under the Third Amended and Restated 2007 Stock Option and Incentive Plan] (Incorporated by reference to Exhibit [removed: 10.2] [added: 10.3] to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, [removed: 2017,] [added: 2016,] filed August 4, [removed: 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000013/podd-exx102_20170630x10q.htm)] [added: 2016](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000094/podd-exx103_20160630x10q.htm))] | | |

| 10.7* | | | [Form of [added: Executive Officer 3 Year Incentive Stock Option Agreement under the] Insulet Corporation [removed: 2017] [added: Third Amended and Restated 2007] Stock Option and Incentive Plan [removed: Restricted Stock Unit Agreement for Directors] (Incorporated by reference to Exhibit [removed: 10.3] [added: 10.7] to our Quarterly Report on Form 10-Q for the fiscal quarter ended [removed: June 30,] [added: March 31,] 2017, filed [removed: August 4, 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000013/podd-exx103_20170630x10q.htm)] [added: May 9, 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000009/podd-exx107_2017331x10q.htm)] | | |

| [removed: 10.8*] [added: 10.4*] | | | [Form of Insulet Corporation 2017 Stock Option and Incentive Plan Non-Qualified Stock Option Agreement (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed February 24, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000015/podd-2022x02x24ex101.htm) | | |

| [removed: 10.9*] [added: 10.5*] | | | [Form of Insulet Corporation 2017 Stock Option and Incentive Plan Performance Shares Agreement (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed March 1, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000018/podd-2022x03x01ex101.htm) | | |

| [removed: 10.10*] [added: 10.6*] | | | [Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Appendix A to our Definitive Proxy Statement on Schedule 14A filed on April 2, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000119312515117872/d864077ddef14a.htm#toc864077_12) | | |

| 10.11* | | | [Form of [removed: Executive Officer 3 Year] [added: Vice President] Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit [removed: 10.7] [added: 10.64] to our [removed: Quarterly] [added: Annual] Report on Form [removed: 10-Q] [added: 10-K] for the fiscal [removed: quarter] [added: year] ended [removed: March] [added: December] 31, [removed: 2017,] [added: 2015,] filed [removed: May 9, 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000009/podd-exx107_2017331x10q.htm)] [added: February 29, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1064_20151231x10k.htm)] | | |

| [removed: 10.12*] [added: 10.14*] | | | [Form of [removed: International] Non-Qualified Stock Option Agreement [added: for Company Employees] under the [removed: Third] [added: Second] Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit [removed: 10.1] [added: 10.4] to our Quarterly Report on Form 10-Q for the fiscal quarter ended [removed: June] [added: September] 30, [removed: 2016,] [added: 2014,] filed [removed: August 4, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000094/podd-exx101_20160630x10q.htm)] [added: November 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex104_20140930x10q.htm)] | | |

| [removed: 10.13*] [added: 10.15*] | | | [Form of Non-Qualified Stock Option Agreement for Non-Employee Directors under the [removed: Third] [added: Second] Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit [removed: 10.3] [added: 10.5] to our Quarterly Report on Form 10-Q for the fiscal quarter ended [removed: June] [added: September] 30, [removed: 2016,] [added: 2014,] filed [removed: August 4, 2016](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000094/podd-exx103_20160630x10q.htm))] [added: November 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex105_20140930x10q.htm)] | | |

| [removed: 10.14*] [added: 10.9*] | | | [Form of Non-Executive Employee Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.60 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed February 29, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1060_20151231x10k.htm) | | |

| [removed: 10.15*] [added: 10.10*] | | | [Form of Section 16 Officer Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.62 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed February 29, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1062_20151231x10k.htm) | | |

| [removed: 10.16*] [added: 10.13*] | | | [Form of [removed: Vice President] Incentive Stock Option Agreement under the [removed: Insulet Corporation Third] [added: Second] Amended and Restated 2007 Stock Option and Incentive Plan [added: - 2015 Sales Plan] (Incorporated by reference to Exhibit [removed: 10.64] [added: 10.51] to our Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2015,] [added: 2014,] filed February [removed: 29, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1064_20151231x10k.htm)] [added: 26, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000020/poddex1051_2014311210k.htm)] | | |

| [removed: 10.17*] [added: 10.16*] | | | [Form of Incentive Stock Option Agreement under the [removed: Insulet Corporation Third] [added: Second] Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit [removed: 10.4] [added: 10.7] to our Quarterly Report on Form 10-Q for the fiscal quarter ended [removed: June] [added: September] 30, [removed: 2015,] [added: 2014,] filed [removed: August 12, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000059/podd-ex104_20150630x10q.htm)] [added: November 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex107_20140930x10q.htm)] | | |

| 10.18* | | | [Form of [removed: Incentive] [added: Non-Qualified] Stock Option Agreement [added: for Section 16 Officers] under the Second Amended and Restated 2007 Stock Option and Incentive Plan [removed: - 2015 Sales Plan] (Incorporated by reference to Exhibit [removed: 10.51] [added: 10.11] to our [removed: Annual] [added: Quarterly] Report on Form [removed: 10-K] [added: 10-Q] for the fiscal [removed: year] [added: quarter] ended [removed: December 31,] [added: September 30,] 2014, filed [removed: February 26, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000020/poddex1051_2014311210k.htm)] [added: November 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex1011_20140930x10q.htm)] | | |

| 10.19* | | | [Form of [removed: Non-Qualified] [added: Incentive] Stock Option Agreement [removed: for Shacey Petrovic] under the Second Amended and Restated 2007 Stock Option and Incentive Plan [added: - October 2014 New Hires] (Incorporated by reference to Exhibit [removed: 10.53] [added: 10.15] to our [removed: Annual] [added: Quarterly] Report on Form [removed: 10-K] [added: 10-Q] for the fiscal [removed: year] [added: quarter] ended [removed: December 31,] [added: September 30,] 2014, filed [removed: February 26, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000020/poddex1053_2014123110k.htm)] [added: November 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd_ex1015x20140903-10q.htm)] | | |

| [removed: 10.28*] [added: 10.24*] | | | [Amended and Restated Executive Severance Plan (Incorporated by reference to Exhibit 10.4 to our Current Report on Form 8-K filed February 22, 2023)](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000011/podd-2023x02x22ex104.htm) | | |

| [removed: 10.29*] [added: 10.25*] | | | [Insulet Corporation Employee Stock Purchase Plan (Amended and Restated February 27, 2019) (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed May 30, 2019)](http://www.sec.gov/Archives/edgar/data/1145197/000114519719000023/insuletcorporationemployee.htm) | | |

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

| 10.31* | | | [Offer Letter between [removed: Shacey Petrovic] [added: James R. Hollingshead] and Insulet Corporation, dated [removed: September 10, 2018] [added: May 4, 2022] (Incorporated by reference to Exhibit 10.1 to our Current Report on Form [removed: 8-K] [added: 8-K,] filed [removed: September 14, 2018)](http://www.sec.gov/Archives/edgar/data/1145197/000115752318001929/a51865882ex10_1.htm)] [added: May 6, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex101.htm)] | | |

| [removed: 10.32*] [added: 10.29*] | | | [Offer Letter between [removed: Wayde D. McMillan] [added: John W. Kapples] and Insulet Corporation, dated January [removed: 3,] [added: 22,] 2019 (Incorporated by reference to Exhibit [removed: 10.1] [added: 10.2] to our [removed: Current] [added: Quarterly] Report on Form [removed: 8-K] [added: 10-Q,] filed [removed: on January 7, 2019)](http://www.sec.gov/Archives/edgar/data/1145197/000115752319000039/a51922220ex10_1.htm)] [added: May 3, 2019).](http://www.sec.gov/Archives/edgar/data/1145197/000114519719000020/podd-exx102_20190331x10q.htm)] | | |

| [removed: 10.33+] [added: 10.60+] | | | [Master Equipment and Services Agreement between Insulet Corporation and ATS Automated Tooling Systems Inc., dated August 31, 2016 (Incorporated by reference to Exhibit 10.2 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2016, filed November 4, [removed: 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000100/podd-exx102_2016930x10q.htm)] [added: 2016)](https://www.sec.gov/Archives/edgar/data/1145197/000114519716000100/podd-exx102_2016930x10q.htm)] | | |

| [removed: 10.34] [added: 10.41] | | | [Purchase and Sale Agreement by and between 100 Nagog Park Limited Partnership and Insulet Corporation, dated December 16, 2016 (Incorporated by reference to Exhibit 1.1 to our Current Report on Form 8-K filed December 20, 2016 (Items 1.01 and [removed: 9.01)](http://www.sec.gov/Archives/edgar/data/1145197/000115752316007605/a51481585ex1_1.htm)] [added: 9.01)](https://www.sec.gov/Archives/edgar/data/1145197/000115752316007605/a51481585ex1_1.htm)] | | |

| [removed: 10.35+] [added: 10.42+] | | | [Supply Agreement, dated November 21, 2013, between Amgen and Insulet Corporation, as amended by Amendment No. 1 through Amendment No. 14 (Incorporated by reference to Exhibit 10.18 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, filed February 28, [removed: 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000005/podd-exx1018_20161231x10k.htm)] [added: 2017)](https://www.sec.gov/Archives/edgar/data/1145197/000114519717000005/podd-exx1018_20161231x10k.htm)] | | |

| [removed: 10.36+] [added: 10.44+] | | | [Amendment No. 16, entered into effective as of August 15, 2018, to Supply Agreement, dated November 21, 2013, between Amgen Inc. and Insulet Corporation (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2018, filed November 1, [removed: 2018)](http://www.sec.gov/Archives/edgar/data/1145197/000114519718000015/podd-exx101_20180930x10q.htm)] [added: 2018)](https://www.sec.gov/Archives/edgar/data/1145197/000114519718000015/podd-exx101_20180930x10q.htm)] | | |

| [removed: 10.37] [added: 10.34] | | | [Form of Capped Call Transactions Confirmation (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed September 9, [removed: 2019).](http://www.sec.gov/Archives/edgar/data/1145197/000119312519240972/d766132dex101.htm)] [added: 2019)](https://www.sec.gov/Archives/edgar/data/1145197/000119312519240972/d766132dex101.htm)] | | |

| [removed: 10.38*] [added: 10.32*] | | | [removed: [Offer Letter] [added: [Retirement and Advisory Agreement] between [removed: John W. Kapples] [added: Shacey Petrovic] and Insulet Corporation, dated [removed: January 22, 2019] [added: May 4, 2022] (Incorporated by reference to Exhibit 10.2 to our [removed: Quarterly] [added: Current] Report on Form [removed: 10-Q,] [added: 8-K,] filed May [removed: 3, 2019).](http://www.sec.gov/Archives/edgar/data/1145197/000114519719000020/podd-exx102_20190331x10q.htm)] [added: 6, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex102.htm)] | | |

| [removed: 10.39*] [added: 10.30*] | | | [Offer Letter between Dan Manea and Insulet Corporation, dated March 19, 2020 (Incorporated by reference to Exhibit 10.56 to our Annual Report on Form 10-K [added: for the fiscal year ended December 31, 2020,] filed February 24, 2021).](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1056_20201231x10k.htm) | | |

| [removed: 10.40*] [added: 10.63++] | | | [removed: [Offer Letter between James R. Holling](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex101.htm)[s](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex101.htm)[head] [added: [Patent Assignment] and [added: License Agreement, dated February 9, 2023, between] Insulet Corporation, [removed: dated May 4, 2022] [added: Bigfoot Biomedical, Inc. and Patients Pending, Ltd.] (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed [removed: May](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex101.htm) [6](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex101.htm)[, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex101.htm)] [added: February 14, 2023)](https://www.sec.gov/Archives/edgar/data/1145197/000114519723000004/podd-2023x02x14ex101.htm)] | | |

| [removed: 10.41*] [added: 10.55++] | | | [removed: [Retirement and Advisory] [added: [Data] Agreement [removed: between Shacey Petrovic] [added: by] and [added: between] Insulet [removed: Corporation,] [added: Corporation and DexCom, Inc,] dated May [removed: 4, 2022] [added: 7, 2020] (Incorporated by reference to Exhibit [removed: 10.2] [added: 10.4] to our [removed: Current] [added: Quarterly] Report on Form [removed: 8-K,] [added: 10-Q for the fiscal quarter ended June 30, 2022,] filed [removed: May](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex102.htm) [6](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex102.htm)[, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000030/podd-2022x05x05ex102.htm)] [added: August 5, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000046/podd-exx104_2022x06x30x10q.htm)] | | |

| [removed: 10.42] [added: 10.35] | | | [Credit Agreement, dated as of May 4, 2021, by and among Insulet Corporation, the lenders and other parties party thereto and Morgan Stanley Senior Funding, Inc., as administrative agent and collateral agent (Incorporated by reference to Exhibit 10.1 [removed: to](https://www.sec.gov/Archives/edgar/data/1145197/000119312521150953/d180998dex101.htm) [our](https://www.sec.gov/Archives/edgar/data/1145197/000119312521150953/d180998dex101.htm) [Current] [added: to our Current] Report on Form 8-K filed May 5, 2021).](https://www.sec.gov/Archives/edgar/data/1145197/000119312521150953/d180998dex101.htm) | | |

| [removed: 10.43] [added: 10.36] | | | [Incremental Amendment to Credit Agreement, dated June 15, 2022, among Insulet Corporation, Insulet MA Securities Corporation, Morgan Stanley Senior Funding, Inc., as administrative agent, swingline lender, and letter of credit issuer, and the other lenders party thereto (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed June [removed: 1](https://www.sec.gov/Archives/edgar/data/1145197/000119312522174941/d477416dex101.htm)[6](https://www.sec.gov/Archives/edgar/data/1145197/000119312522174941/d477416dex101.htm)[,] [added: 16,] 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000119312522174941/d477416dex101.htm) | | |

| [removed: 10.44] [added: 10.37] | | | [Second Amendment to Credit Agreement, dated November 30, 2022, between Insulet Corporation and Morgan Stanley Senior Funding, Inc., as administrative agent (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed December 1, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000119312522295969/d420238dex101.htm) | | |

| [removed: 10.45] [added: 10.38] | | | [Third Amendment to Credit Agreement, dated November 30, 2022, between Insulet Corporation, Insulet MA Securities Corporation, the lenders and other parties thereto and Morgan Stanley Senior Funding, Inc., as administrative agent (Incorporated by reference to Exhibit 10.2 to our Current Report on Form 8-K, filed December 1, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000119312522295969/d420238dex102.htm) | | |

| [removed: 10.46++] [added: 10.50++] | | | [Materials Supplier Agreement between Insulet Corporation and Sanmina Corporation, dated October 11, [removed: 2018.](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1043_20211231x10k.htm) [](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1043_20211231x10k.htm)[(Incorporated] [added: 2018. (Incorporated] by reference to Exhibit 10.43 to our Annual Report on Form 10-K [added: for the fiscal year ended December 31, 2021,] filed February 24, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1043_20211231x10k.htm) | | |

| [removed: 10.47++] [added: 10.51++] | | | [First Amendment to Materials Supplier Agreement between Insulet Corporation and Sanmina Corporation, dated October 1, [removed: 2020.](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1044_20211231x10k.htm) [](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1044_20211231x10k.htm)[(Incorporated] [added: 2020. (Incorporated] by reference to Exhibit [removed: 10.4](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1044_20211231x10k.htm)[4](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1044_20211231x10k.htm) [to] [added: 10.44 to] our Annual Report on Form 10-K [added: for the fiscal year ended December 31, 2021,] filed February 24, 2022)](https://www.sec.gov/Archives/edgar/data/1145197/000114519722000012/podd-ex1044_20211231x10k.htm) | | |