Insulet (PODD) 10-K risk factor changes: FY2021 vs FY2020

- the failure of the Omnipod System to achieve and maintain wide acceptance among opinion leaders in the diabetes treatment community, insulin-prescribing physicians, third-party [removed: payors] [added: payors,] and people with insulin-dependent diabetes;

- damage, destruction or loss of any of the facilities where our products are manufactured or stored or of the equipment [removed: therein or failure to successfully open or expand new facilities;][added: therein;]

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

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

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

We will need to manage our supply chain effectively, including the continued development of our manufacturing and our relationships with our contract [removed: manufacturers] [added: manufacturer] and other suppliers.

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

[removed: In the United States, we] [added: We] began [removed: selling] [added: our full market release of] Omnipod DASH in 2019, primarily through the pharmacy channel, which required negotiation of new or amended agreements with our intermediaries and payors.

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

The medical device industry is intensely competitive, subject to rapid change [removed: and significantly affected by new product introductions] [added: resulting from technological advances] and [added: scientific discoveries as well as] other market activities of industry participants.

Medtronic has been the [added: insulin pump] market leader for many [removed: years in the United States.][added: years.]

In addition to the established insulin pump competitors, several companies are working to develop and market new insulin “patch” [removed: pumps] [added: pumps, smart pens,] and other methods for the treatment of diabetes.

[removed: Many] [added: Some] of our competitors are large, well-capitalized companies with more resources than we have.

While we believe that pump therapy, in general, and the Omnipod System, in particular, have significant competitive and clinical advantages over [removed: traditional] MDI therapy, improvements in the effectiveness of MDI therapy may result in fewer people with insulin-dependent diabetes converting from MDI therapy to pump therapy than we expect and may result in negative price pressure.

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

[removed: If these third parties do] not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, or if the quality or accuracy of the data they obtain is compromised due to failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our pre-clinical development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize, our products on a timely basis, or at all, and our business and operating results may be adversely affected.

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

We rely on a combination of patents, trade secrets, copyright and trademark laws, confidentiality, non-disclosure and assignment of invention agreements [added: and other contractual provisions and technical measures to protect our intellectual property rights.]

Our ability to compete depends in part on our continued ability to develop or acquire commercially valuable [removed: patent] [added: intellectual property] rights and to protect those rights adequately.

Further, we cannot ensure that our pending patent applications will result in the issuance of patents to us, that patents issued to or licensed by [added: or to] us in the past or in the future will not be challenged or circumvented by competitors or that these patents will be found to be valid or 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 [added: internationally] may be limited in certain [removed: circumstances outside the United States.][added: circumstances.]

For example, we may not be able to protect our intellectual property rights effectively in China, where we rely on [added: a] third-party contract [removed: manufacturers] [added: 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, [removed: non-disclosure] [added: non-disclosure,] or assignment of invention agreements, may not be successful.

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

A court could determine that some or all of our asserted intellectual property rights are not infringed, or are [removed: invalid] [added: invalid,] or unenforceable.

We have settled infringement suits in the past and as disclosed in Note [removed: 13] [added: 17] to the consolidated financial statements included in Item 8, we are currently subject to patent infringement litigation with Roche Diabetes Care, Inc. In addition, we expect that we could be increasingly subject to third-party infringement claims as our revenue increases, the number of competitors grows and the functionality of products and technology in different industry segments overlaps.

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

A court could enter orders that temporarily, preliminarily or permanently enjoin [removed: our customers] [added: consumers] from using our products or us from manufacturing, selling, or importing our products, or could enter an order mandating that we undertake certain remedial activities.

The pandemic and preventative measures taken to contain or mitigate the outbreak, [added: including vaccine mandates,] have caused, and are continuing to cause, business slowdown or shutdown in affected [removed: areas] [added: areas, supply chain disruptions, labor shortages, inflation] and disruption in the financial markets globally.

As a result, consumers may reduce their spending, new orders for our Omnipod System may decline and our [removed: customer] [added: user] attrition rate may increase, which could have a material adverse effect on our business, sales, financial condition and results of operations.

[removed: The remote work environment has] [added: These] increased risks [removed: associated with our information technology systems and networks, including] [added: include] cyber-attacks, computer viruses, disruptions, or shutdowns that could result in a failure to protect our information technology systems and data integrity.

For example, the COVID-19 pandemic may divert healthcare resources away from the conduct of clinical trials and interrupt the operations of the FDA and comparable foreign regulatory agencies, which could delay product approval timelines, [removed: including] [added: as it did] for [removed: our] Omnipod 5.

[removed: We] [added: In addition to the United States, we] sell the Omnipod System in Europe, [removed: Canada and] [added: Canada,] the Middle [removed: East.][added: East and Australia.]

Our [added: international] operations [removed: outside of the United States] are subject to risks that are inherent in conducting business under [removed: non-U.S.] [added: foreign] laws, regulations and customs.

[removed: Sales outside the United States] [added: International sales] made up [removed: approximately] one third of our revenues in [removed: 2020] [added: 2021] and we expect [removed: non-U.S.] [added: international] sales to contribute significantly to our future growth.

We also rely on third-party suppliers located [removed: outside the United States.][added: in other countries.]

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

Ultimately, the investment required for expansion into [removed: foreign] [added: international] markets could exceed the results of operations generated from this expansion.

- difficulty in establishing, staffing and managing [removed: non-U.S.] [added: international] operations;

- adapting to the differing laws and regulations, business and clinical practices, and consumer preferences in [removed: foreign] [added: international] markets;

- failure to successfully open or expand new facilities;

For example, we are currently working to implement a new enterprise resource planning system and significantly upgrade our customer relationship management system.

We also compete with Medtronic and Tandem, among others.

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

If these third parties do

We operate in an industry characterized by extensive patent litigation.

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

Any change in the laws or regulations that govern

harm our reputation.

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

The increased scope of regulation around the world may require expanded compliance programs and resources.

As our efforts to gain insights from data increase for the operation of our products and services and for the improvement of business processes, including sales and marketing, our exposure to increasingly complex privacy regulation may impede our ability to use data in this way.

Many of our information systems are cloud-hosted and managed by third-party vendors, some of which may have access to confidential business, employee, healthcare professional, and/or customer information.

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

(This vulnerability does not exist in Omnipod DASH or Omnipod 5.) Successful exploitation of this vulnerability may allow an attacker to gain access to the Pod to intercept, modify, or interfere with the wireless RF communications to or from the PDM.

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

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

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

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

This practice does not exist with Omnipod 5.

However, the ever-evolving threats mean we must continually evaluate and adapt our

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

Our Credit Agreement imposes restrictions on us that may adversely affect our ability to operate our business.

Our Credit Agreement contains covenants that restrict our ability, and that of our subsidiaries, to engage in certain transactions, including, among other things, limitations on our ability to incur additional indebtedness, make asset dispositions, create or permit liens, sell, transfer or exchange assets, guarantee certain indebtedness and make acquisitions or other investments.

These restrictions may impair our ability to respond to changing business and economic conditions and may make it more difficult for us to obtain additional capital and to pursue business opportunities, including potential acquisitions.

We face intense competition for employees, particularly in light of recent labor shortages and as people are increasingly able to work remotely.

We face challenges in maintaining employee well-being, recognizing that the additional financial, family, and health burdens that many employees may be experiencing due to the COVID-19 pandemic and related economic uncertainties may adversely impact job performance and employee retention.

For example, in January 2022, we acquired one of our suppliers.

We cannot accurately predict the complete

impact of these healthcare reform initiatives, but they could lead to a decreased demand for our products and other outcomes that could adversely impact our business and financial results.

Some of the provisions of the ACA have yet to be fully implemented, and certain provisions have been subject to judicial and Congressional challenges.

In addition, there have been efforts to repeal or replace certain aspects of the ACA and to alter the implementation of the ACA and related laws.

For example, the Tax Cuts and Jobs Act that was signed into law on December 22, 2017 eliminated the shared responsibility payment for individuals who fail to maintain minimum essential coverage, commonly referred to as the “individual mandate”.

Further, the Bipartisan Budget Act of 2018 among other things, amended the Medicare statute to reduce the coverage gap in most Medicare drug plans, commonly known as the “donut hole,” by raising the manufacturer discount under the Medicare Part D coverage gap discount program to 70%.

Other suppliers we compete with include Tandem in the United States and Roche and Ypsomed outside the United States.

new delivery devices, delivery technologies, sensing technologies, procedures, drugs and other therapeutics for the monitoring, treatment and/or prevention of insulin-dependent diabetes.

and other contractual provisions and technical measures to protect our intellectual property rights.

Substantial litigation over intellectual property rights exists in the medical device industry.

This has led to a significant increase in unemployment and a loss of employee-sponsored insurance coverage for many people in the United States.

As a result of the COVID-19 pandemic, we have transitioned to a remote work environment for those employees who can perform their job function outside of our facilities.

We operate

- our suppliers manufacture products for a range of customers, and fluctuations in demand for the products these suppliers manufacture for others may affect their ability to deliver products to us in a timely manner;

Medical device manufacturers are required to report to the FDA information that a device has or may have caused or contributed to a death or serious injury or has malfunctioned in a way that would likely cause or contribute to death or serious injury if the malfunction of the device or one of our similar devices were to recur.

Any such adverse event involving our products could result in voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection or enforcement action.

health consequences or death.

Recalls of any of our products would divert managerial and financial resources and could have an adverse effect on our reputation, results of operations and financial condition, and impair our ability to produce our products in a cost-effective and timely manner in order to meet our customers’ demands.

The form and function of such systems may change over time as our business needs change.

We cannot guarantee that we will maintain a level of cash flows from operating activities sufficient to permit us to repay the principal or service our interest.

Over the last several years, we have made significant changes to our senior management team and to many other positions throughout the Company.

We believe we will benefit substantially from the leadership and performance of these new and promoted employees.

In addition, it is important to the success of the Company that the transition of new and promoted employees and executives be largely seamless.

Competition for senior management personnel, and other highly

skilled personnel is intense and there can be no assurances that we will be able to retain our personnel.

The Omnipod System features a small, lightweight, self-adhesive disposable tubeless Omnipod device that is worn on the body for up to three days at a time; and its wireless companion, the handheld [removed: PDM.][added: PDM/Controller.]

The Omnipod System, which features discreet and easy-to-use devices, communicates wirelessly, provides for virtually pain-free automated cannula insertion and eliminates the need for [removed: traditional] MDI therapy or the use of [removed: traditional] pump and tubing.

Most of our drug delivery revenue currently consists of sales of pods to Amgen for use in the Neulasta® Onpro® kit, a delivery system for Amgen’s [removed: white blood cell booster] [added: Neulasta] to help reduce the risk of infection after intense chemotherapy.

- [removed: driving] [added: expanding] access and awareness;

- [removed: expanding] [added: growing] our global addressable market; and

[removed: Based on the results of the] [added: We have also recently completed our type 2] feasibility [removed: work, we] [added: study and] plan to conduct additional studies with the goal to further expand Omnipod 5’s [removed: indications.][added: indication to type 2 users.]

In [removed: 2020,] [added: 2021,] we completed [removed: the roll out] [added: our full commercial launch] of Omnipod DASH, our digital mobile Omnipod platform, in the countries we serve [added: with our roll out] in [removed: Europe.][added: Canada.]

[removed: We] [added: Over the long term, we] expect the introduction of Omnipod DASH throughout our international markets to be a growth driver as we increase our presence within our existing markets and enter into new [removed: countries over the long term.][added: countries.]

Finally, we plan to continue [removed: our product development efforts and] [added: to] expand awareness of and access to our [removed: products.][added: products, while also focusing on our product development efforts.]

The discussion of our results of operations for [removed: 2018] [added: 2019] 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: 2019] [added: 2020] filed with the Securities and Exchange Commission on February [removed: 26, 2020.][added: 24, 2021.]

Comparison of the Years Ended December 31, [removed: 2020] [added: 2021] and December 31, [removed: 2019][added: 2020]

| (In millions) | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | % Change | | | | | | Currency Impact | | | | | | Constant Currency(1) | | |

| U.S. Omnipod | | | $ | [removed: 526.9] [added: 651.5] | | | | | $ | [removed: 420.4] [added: 526.9] | | | | | [removed: 25.3] [added: 23.6] | | % | | | | — | | % | | | | [removed: 25.3] [added: 23.6] | | % |

| Drug Delivery | | | [removed: 69.5] [added: 87.4] | | | | | | [removed: 64.7] [added: 69.5] | | | | | | [removed: 7.4] [added: 25.8] | | % | | | | — | | % | | | | [removed: 7.4] [added: 25.8] | | % |

Total revenue for [removed: 2020] [added: 2021] increased [removed: $166.2] [added: $194.4] million, or [removed: 22.5%,] [added: 21.5%,] to [removed: $904.4] [added: $1,098.8] million, compared with [removed: $738.2] [added: $904.4] million in [removed: 2019.][added: 2020.]

Constant currency revenue growth of [removed: 21.9%] [added: 19.7%] was primarily driven by higher volume and, to a lesser extent, favorable sales channel mix.

U.S. Omnipod revenue for [removed: 2020] [added: 2021] increased [removed: $106.5] [added: $124.6] million, or [removed: 25.3%,] [added: 23.6%,] to [removed: $526.9] [added: $651.5] million, compared with [removed: $420.4] [added: $526.9] million in [removed: 2019.][added: 2020.]

This increase was primarily due to higher volumes driven by growing our customer base and, to a lesser extent, an increase due to growth through the pharmacy channel, where Pods have a higher average selling price [removed: due] [added: from our pay-as-you-go pricing model] in [removed: part to the fact that] [added: which] we offer the PDM for no charge.

In [removed: 2021,] [added: 2022,] we expect strong Omnipod revenue growth driven by continued [removed: market penetration and] volume growth of Omnipod DASH, primarily in the pharmacy channel.

International Omnipod revenue for [removed: 2020] [added: 2021] increased [removed: $54.9] [added: $51.9] million, or [removed: 21.7%,] [added: 16.9%,] to [removed: $308.0] [added: $359.9] million, compared with [removed: $253.1] [added: $308.0] million in [removed: 2019.][added: 2020.]

Excluding the [removed: 1.8%] [added: 5.3%] favorable impact of currency exchange, the remaining [removed: 19.9%] [added: 11.6%] increase was primarily due to higher volumes as we continue to expand awareness and access to the [removed: Omnipod.][added: Omnipod, partially offset by the normalization of inventory]

[removed: Similar to in the U.S., in 2021,] [added: In 2022,] we expect higher International Omnipod revenue due to continued volume growth and market penetration aided by the [removed: full launch] [added: ongoing adoption] of Omnipod DASH throughout our international [removed: markets and our virtual training capabilities.][added: markets.]

Drug Delivery revenue for [removed: 2020] [added: 2021] increased [removed: $4.8] [added: $17.9] million, or [removed: 7.4%,] [added: 25.8%,] to [removed: $69.5] [added: $87.4] million, compared with [removed: $64.7] [added: $69.5] million in [removed: 2019.][added: 2020.]

| Cost of revenue | | | $ | [removed: 322.1] [added: 346.7] | | | | | [removed: 35.6] [added: 31.6] | | % | | | | $ | [removed: 257.9] [added: 322.1] | | | | | [removed: 34.9] [added: 35.6] | | % |

| Research and development expenses | | | $ | [removed: 146.8] [added: 160.1] | | | | | [removed: 16.2] [added: 14.6] | | % | | | | $ | [removed: 132.3] [added: 146.8] | | | | | [removed: 17.9] [added: 16.2] | | % |

| Selling, general and administrative expenses | | | $ | [removed: 384.0] [added: 466.0] | | | | | [removed: 42.5] [added: 42.4] | | % | | | | $ | [removed: 298.0] [added: 384.0] | | | | | [removed: 40.4] [added: 42.5] | | % |

Cost of revenue for [removed: 2020] [added: 2021] increased [removed: $64.2] [added: $24.6] million, or [removed: 24.9%,] [added: 7.6%,] to [removed: $322.1] [added: $346.7] million, compared with [removed: $257.9] [added: $322.1] million in [removed: 2019.][added: 2020.]

Gross margin was [removed: 64.4%] [added: 68.4%] in [removed: 2020,] [added: 2021,] compared with [removed: 65.1%] [added: 64.4%] in [removed: 2019.][added: 2020.]

The [removed: 70] [added: 400] basis point [removed: decrease] [added: increase] in gross margin was primarily [removed: due to start-up costs and inefficiencies] driven by [removed: the addition of the second line at our U.S.] [added: improved] manufacturing [removed: facility, as well] [added: efficiencies, higher average selling price due to growth in the pharmacy channel and a decrease in COVID-19 related costs,] as [added: the prior year included a period expense for] two months of [removed: higher] depreciation [removed: expense] for under-utilized plant capacity, recruiting and screening expenses, expedited shipping costs and manufacturing incentives totaling $8.5 million, primarily associated with our contract manufacturer in [removed: China as a result of COVID-19.][added: Shenzhen, China.]

Research and development expenses for [removed: 2020] [added: 2021] increased [removed: $14.5] [added: $13.3] million, or [removed: 11.0%,] [added: 9.1%,] to [removed: $146.8] [added: $160.1] million, compared with [removed: $132.3] [added: $146.8] million in [removed: 2019.][added: 2020.]

We expect research and development spending in [removed: 2021] [added: 2022] to increase compared with [removed: 2020] [added: 2021] as we continue to invest in advancing our innovation and clinical [removed: pipeline.][added: pipeline and contend with inflation.]

Selling, general and administrative expenses for [removed: 2020] [added: 2021] increased [removed: $86.0] [added: $82.0] million, or [removed: 28.9%,] [added: 21.4%,] to [removed: $384.0] [added: $466.0] million, compared with [removed: $298.0] [added: $384.0] million in [removed: 2019.][added: 2020.]

[removed: This increase was primarily attributable to investments in customer support and other initiatives to support our growth, including year-over-year headcount additions, mainly sales and customer service personnel, $18.8 million increase in advertising expense driven] [added: These increases were partially offset] by [removed: the pilot of our direct-to-consumer advertising campaign and online advertising,] $14.6 million of cumulative amortization expense [added: in the prior year] related to the resolution of a purchase price contingency associated with the acquisition of customer relationships from a former European distributor [removed: on July 1,] [added: in] 2018, [removed: as well as] [added: and] $4.8 million of stock-based compensation expense [added: in the prior year resulting] from a company-wide 20th anniversary equity [removed: grant,] [added: grant to non-executives,] a significant portion of which vested immediately.

We expect selling, general and administrative expenses to increase in [removed: 2021] [added: 2022] compared with [removed: 2020] [added: 2021] due to expansion of our [removed: U.S.] sales force and customer support personnel, investments to expand market acceptance and access for [added: the] Omnipod [removed: 5,] [added: System,] including direct-to-consumer advertising, and investments in our operating structure to facilitate operational efficiencies and continued growth.

Interest expense, net for [removed: 2020] [added: 2021] increased [removed: $17.4] [added: $16.1] million, or [removed: 62.8%,] [added: 35.7%,] to [removed: $45.1] [added: $61.2] million, compared with [removed: $27.7] [added: $45.1] million in [removed: 2019.][added: 2020.]

During [removed: 2019,] [added: 2021,] we incurred [removed: an $8.7] [added: a $42.4] million loss on extinguishment of debt related to the repurchase [added: and conversion] of [added: all of] our [removed: 1.25%] [added: outstanding 1.375%] Notes.

*Other [added: (Expense)] Income, Net*

Income tax expense was [removed: $2.9] [added: $3.7] million on pre-tax income of [removed: $9.7] [added: $20.5] million [added: for 2021] and [removed: $14.5] [added: $2.9] million [added: on pre-tax income of $9.7 million] for [removed: both 2020 and 2019, respectively.][added: 2020.]

Our effective tax rate was [removed: 29.6%] [added: 18.2%] and [removed: 19.8%] [added: 29.6%] for [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] respectively.

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

Our limited market release of Omnipod 5 is underway.

Additionally, we have completed our FDA submission to expand Omnipod 5’s indication down to age two, and are planning for an expanded indication in 2022.

In our efforts to bring Omnipod 5 to international markets, we have submitted for CE Marking in Europe under MDR.

In order to support our continued growth and the full commercial launch of Omnipod 5, we continue to focus on adding capacity to our U.S. manufacturing plant.

During 2021, we began producing salable product on our third highly automated manufacturing line.

We have also taken steps to strengthen our global manufacturing capabilities.

We have optimized our operations in China by consolidating our production in that region into one location and we plan to invest in a new manufacturing plant in another international location to further diversify globally and increase efficiency to drive higher gross margins over time.

During 2021, we increased our global footprint by expanding into Turkey and entered the Asia Pacific region with our launch in Australia.

In 2022.

we expect to enter additional countries in the Middle East.

Further, we are working to bring Omnipod 5 to our international markets.

The latter includes enhancing the customer experience through digital product offerings.

Factors Affecting Operating Results

Our Pods are intended to be used continuously for up to three days and then be replaced with a new disposable Pod.

We recently achieved a milestone of approximately 300,000 global customers using Omnipod.

As we grow our customer base, we generate an increasing portion of our revenue through recurring sales of our Pods, which provides consistent cash flow.

Our recurring revenue business model, alongside the Omnipod System’s unique patented design enables us to provide pump therapy at a low or no up-front investment in regions where reimbursement allows for it.

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

During 2020 and 2021, we were subject to challenging conditions stemming from the coronavirus pandemic (“COVID-19” or the “pandemic”).

Containment efforts and responses to the pandemic have varied by individuals, businesses, state and local municipalities, and region.

We believe people were less likely to change the way they manage their diabetes during the pandemic for a variety of reasons including temporary closure of doctors’ offices or a general unwillingness to visit a doctor’s office or hospital during the pandemic, particularly since those with diabetes are deemed at higher risk of suffering complications from COVID-19.

While the pandemic had a negative impact on new customer starts and the effects will not be fully reflected in our results of operations and overall financial performance until future periods, we believe our overall recurring revenue model provides a solid financial foundation for strong cash flow generation.

Further, the pandemic had a positive impact on our Drug Delivery revenue.

We have also experienced and may continue to experience challenges stemming from the global supply chain disruption; however, to date we have been able to successfully mitigate any disruption.

See “Risk Factors” in Part I, Item 1A of this Annual Report for further discussion of the possible impact of the COVID-19 pandemic on our business.

| International Omnipod | | | 359.9 | | | | | | 308.0 | | | | | | 16.9 | | % | | | | 5.3 | | % | | | | 11.6 | | % |

| Total Omnipod | | | 1,011.4 | | | | | | 834.9 | | | | | | 21.1 | | % | | | | 1.9 | | % | | | | 19.2 | | % |

| Total | | | $ | 1,098.8 | | | | | $ | 904.4 | | | | | 21.5 | | % | | | | 1.8 | | % | | | | 19.7 | | % |

This increase was partially offset by the normalization of inventory levels at distributors, which were elevated in the prior year due to the launch of Omnipod DASH.

This increase was partially offset by the impact of the pandemic on our recurring revenue.

U.S. Omnipod revenue for 2021 includes $58.2 million of related party revenue that resulted from a shift in certain revenues from one distributor to another.

Additional information regarding our related party transactions is provided in Note 5.

levels at distributors, which were elevated in the prior year due to the launch of Omnipod DASH and the impact of the pandemic on our recurring revenue.

We expect this revenue growth to be partially offset by competition from AID systems and the impact of the pandemic on our recurring revenue.

This increase was primarily driven by increased production volume due to higher demand from our partner.

In 2022, we expect Drug Delivery revenue to decline as production levels that were elevated during the pandemic normalize.

| | | | 2021 | | | | | | | | | | | | 2020 | | | | | | | | |

These increases were partially offset by higher production costs as we continue to scale U.S manufacturing.

We expect gross margin for 2022 to be in the range of 67% to 68%.

To achieve this goal, our efforts are focused on the launch of Omnipod 5, powered by Horizon™ (“Omnipod 5”), our AID system.

We completed the first phase of our Omnipod 5 pivotal trial in October.

We also recently completed our Omnipod 5 clinical study of pediatric users ages two to six years old and are planning for an expanded indication by the end of 2021.

In addition, we have begun enrolling individuals with Type 2 diabetes in an Omnipod 5 feasibility study.

During 2020, we began producing salable product on our second highly automated manufacturing line in the U.S. and secured a second contract manufacturer in China, which increased our capacity and redundancy.

Additionally, in order to support our continued growth and the expected launch of Omnipod 5 in the first half of 2021, we recently installed a third highly automated manufacturing line in the U.S. on which salable product is expected in 2021.

In January 2021, we completed our full commercial launch of Omnipod DASH internationally with our roll out in Canada.

The majority of our global customers start on Omnipod DASH.

In 2020, we entered five new countries in Western Europe and the Middle East to expand the commercial sale of Omnipod and our global footprint.

While this expansion into additional countries did not have a material impact on our 2020 revenues, it is expected to contribute to our long-term growth.

In the first quarter of 2021, we expanded into Turkey and we expect to launch Omnipod DASH in Australia in 2021.

Additionally, we are working on our strategy to enter larger markets, such as Asia Pacific and Latin America.

| International Omnipod | | | 308.0 | | | | | | 253.1 | | | | | | 21.7 | | % | | | | 1.8 | | % | | | | 19.9 | | % |

| Total Omnipod | | | 834.9 | | | | | | 673.5 | | | | | | 24.0 | | % | | | | 0.7 | | % | | | | 23.3 | | % |

| Total | | | $ | 904.4 | | | | | $ | 738.2 | | | | | 22.5 | | % | | | | 0.6 | | % | | | | 21.9 | | % |

The COVID-19 pandemic negatively impacted global new customer starts throughout 2020, largely beginning in the second quarter.

We expect our revenues in 2021 to continue to be impacted by the global pandemic's effect on both 2020 and 2021 new customer starts, particularly in our international markets.

We expect this revenue growth to be partially offset by the impact of lower new customer starts in 2020 stemming from COVID-19.

We expect this revenue growth to be partially offset by the impact of lower new customer starts in 2020 stemming from COVID-19 and continued lockdowns in Europe.

This increase was primarily due to increased demand for Amgen’s Neulasta® Onpro® kit which includes our pods.

In 2021, we expect Drug Delivery revenue to decline or grow slightly dependent upon forecasted demand.

| | | | 2020 | | | | | | | | | | | | 2019 | | | | | | | | |

This decrease was partially offset by higher average selling price due to growth in the U.S. pharmacy channel.

We expect gross margin for 2021 to increase to 67% to 70%, which reflects expected revenue growth both in the U.S. and internationally, including in the pharmacy channel, and the benefits of continued improvements in manufacturing and supply chain operations.

This increase was primarily due to year-over-year headcount additions as we focus on driving innovation, particularly Omnipod 5, partially offset by reduced spend on Omnipod DASH, which was launched in the prior year period.

These increases were partially offset by a $9.7 million decrease in travel and entertainment expenses due to reduced activity resulting from COVID-19.

This increase was primarily due to a $9.6 million increase in non-cash interest expense resulting from the net impact of the issuance of $800.0 million of 0.375% convertible notes and the repayment of $402.5 million principal amount of 1.25% convertible notes, a $3.9 million decrease in capitalized interest, primarily due to U.S. manufacturing line 2 being placed in service in the first quarter of 2020, and a $3.9 million decrease in interest income due to lower market rates and a shift in a portion of our investment portfolio to more liquid investments.

Other income, net for 2020 increased $2.4 million, to $3.3 million, compared with $0.9 million in 2019.

This increase was primarily driven by unrealized foreign currency gains due to the change in exchange rates, partially offset by a $1.8 million insurance recovery for damaged inventory in excess of our cost received during the year ended December 31, 2019.

The increase in our effective tax rate primarily resulted from a decrease to pre-tax income in the U.S., which has a valuation allowance.

As of December 31, 2020, we had $907.2 million in cash and cash equivalents and $40.4 million of investments in marketable securities.

| November 2017 | | | | | | 1.375% | | | | | | $ | 402.5 | | | | | November 2024 | | | | | | 10.7315 | | | | | | $93.18 | | |

| Total | | | | | | | | | | | | $ | 1,202.5 | | | | | | | | | | | | | | | | | | | |

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 Convertible Senior Notes.

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

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

The increase in accounts receivable was primarily driven by revenue growth.

The increase in inventories was primarily due to an increase in raw materials and finished goods related to the startup of our U.S. manufacturing plant and an increase in work-in-process to support demand for our product.

Capital expenditures were $163.7 million in 2019 and primarily related to the construction of our manufacturing and corporate headquarters facility in Acton, Massachusetts.

*Option Exercises and Payment of Taxes for Restricted Stock Net Settlements*—Total proceeds from option exercises decreased 20.9 million to $25.7 million in 2020, compared with $46.6 million in 2019.

As of December 31, [removed: 2020,] [added: 2021,] we had outstanding debt related to our convertible senior notes recorded on our consolidated balance sheet of [removed: $933.1] [added: $638.8] million, net of unamortized discount and issuance costs totaling [removed: $269.4] [added: $161.2] million.

The fair value of the [removed: debt,] [added: convertible senior notes,] which was [removed: $2.0 billion] [added: $938.8 million] as of December 31, [removed: 2020,] [added: 2021,] is also impacted by changes in our stock price.

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

Approximately [removed: 34%] [added: 33%] of our revenue was denominated in foreign currencies for the year ended December 31, [removed: 2020.][added: 2021.]

Net realized and unrealized gains (losses) from foreign currency transactions are included in other [removed: income (expense),] [added: (expense) income,] net in the consolidated statement of income and amounted to a loss of [removed: $3.2] [added: $2.0] million for the year ended December 31, [removed: 2020.][added: 2021.]

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

At December 31, 2021, no amounts were outstanding under our Revolving Credit Facility.

In May 2021, we entered into two interest rate swap agreements to effectively convert $480.0 million of our term loan borrowings from a variable rate to a fixed rate.

These interest rate swaps are intended to mitigate the exposure to fluctuations in interest rates and qualify for hedge accounting treatment as cash flow hedges.

A 100 basis point increase or decrease in interest rates relative to interest rates as of December 31, 2021 would decrease or increase our annual earnings, respectively, by approximately $0.2 million.

The primary objectives of our investment strategy are to preserve principal, maintain proper liquidity to meet operating needs and maximize yields.

To minimize our exposure to an adverse shift in interest rates, we invest mainly in cash equivalents and short-term investments in a variety of securities, including money market funds, U.S. Treasury debt and corporate debt securities.

Due to the short-term nature of our investments, we believe that we have no material exposure to interest rate risk.

The Omnipod System includes: the Omnipod Insulin Management System [removed: (“Omnipod”) and] [added: (“Omnipod”),] the Omnipod [removed: DASHTM] [added: DASH®] Insulin Management System (“Omnipod [removed: DASH” or “DASH”),] [added: DASH”),] our digital mobile Omnipod [removed: platform.][added: platform and the Omnipod® 5 Automated Insulin Delivery System (“Omnipod 5”).]

Most 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 [removed: white blood cell booster] [added: Neulasta] to help reduce the risk of infection after intense chemotherapy.

Hyperglycemia can lead to serious short-term complications, such as confusion, vomiting, [removed: dehydration] [added: dehydration,] and loss of consciousness and long-term complications, such as blindness, kidney disease, nervous system disease, occlusive vascular diseases, [removed: stroke and] [added: stroke,] cardiovascular disease, or death.

Hypoglycemia can lead to confusion, loss of [removed: consciousness] [added: consciousness,] or death.

We estimate that [added: approximately] four to four and a half million people have [removed: Type] [added: type] 1 diabetes in the countries we currently serve.

Initially, many people with [removed: Type] [added: type] 2 diabetes attempt to manage their diabetes with improvements in diet, [removed: exercise] [added: exercise,] and/or oral medications.

We estimate that approximately seven to seven and a half million people have [removed: Type] [added: insulin-requiring type] 2 diabetes in the countries we currently serve.

We estimate that approximately one-third of the [removed: Type] [added: type] 1 diabetes population in the United States and even less of the [removed: Type] [added: international type] 1 diabetes population [removed: outside the United States] use insulin pump therapy.

An even smaller portion of the [removed: Type] [added: U.S. and international insulin-requiring type] 2 diabetes population [removed: in and outside of the United States who are insulin-dependent] use insulin pump therapy.

Blood glucose levels can be affected by the carbohydrate and fat content of meals, exercise, stress, [removed: illness or] [added: illness,] impending illness, hormonal releases, variability in insulin [removed: absorption] [added: absorption,] and changes in the effects of insulin on the body.

Achieving this result can be very difficult [removed: without] [added: with] multiple daily injections of [removed: insulin or insulin pump therapy.][added: insulin.]

Individuals with diabetes attempting to control their blood glucose levels tightly to prevent the long-term complications associated with fluctuations in blood glucose levels are at greater risk for overcorrection and [removed: the resultant] hypoglycemia.

In addition to 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 [removed: level.][added: level caused by]

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

Insulin pumps [removed: are used to] perform continuous subcutaneous insulin infusion and typically use a programmable device and an infusion set to administer insulin into the [removed: person’s] body.

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

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

We believe the Omnipod System’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, [removed: convenience] [added: convenience,] and ease.

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

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

- the Personal Diabetes Manager [removed: (“PDM”),] [added: (“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.

The Omnipod System communicates wirelessly, provides for virtually pain-free automated cannula [removed: insertion] [added: insertion,] and eliminates the need for [removed: traditional] MDI therapy or the use of [removed: traditional] pump and tubing.

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

The Omnipod System consists of just two devices as opposed to up to seven for [removed: conventional] tubed insulin pumps.

As a result, the Omnipod System is easy to use, which reduces the training burden on healthcare professionals and [removed: end-users.][added: users.]

We believe that the Omnipod System’s overall ease of use, [removed: flexibility] [added: flexibility,] and substantially lower training burden make it very attractive to people with insulin-dependent diabetes and allows healthcare professionals to prescribe pump therapy to a broader group of people with diabetes.

The Omnipod System’s unique patented design [removed: and proprietary manufacturing process] allow us to provide pump therapy at a relatively low or no up-front investment, which reduces the risk to [removed: third-party payors in the U.S., compared to conventional tubed insulin pumps.][added: third-]

Glooko provides a cloud-based application for clinicians and users accessible through a kiosk, home [removed: computer] [added: computer,] or a mobile application on the user’s smartphone that provides users and their [removed: health care] [added: healthcare] providers access to insulin delivery trends, blood glucose [removed: levels] [added: levels,] and other integrated data.

In the United States, our products are sold directly to [added: consumers, as well as] wholesalers, private healthcare organizations, healthcare facilities, mail order [removed: pharmacies] [added: pharmacies,] and independent retailers.

[added: party payors in the U.S.] In certain [removed: non-U.S.] [added: 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.

The Omnipod System is currently available in the [removed: United States, Canada and in certain countries in Europe and the Middle East.][added: following countries:]

For the year ended December 31, [removed: 2020, approximately 70%] [added: 2021, 76%] of our Omnipod System sales were through intermediaries.

[removed: Revenue] [added: The percentages of total revenue] for customers [removed: comprising] [added: that represent] 10% or more of total revenue was as follows:

| | | | [removed: | | |] Years Ended December 31, | | | | | | | | | | | | | | |

| | | | [removed: | | | 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2018] [added: 2019] | | |

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

We have a [removed: uniform] [added: comprehensive] sales and marketing approach, [removed: aligned across users, physicians and providers, to capitalize on] [added: which communicates] the [removed: unique] benefits of [removed: our] [added: the] Omnipod System [removed: technology.][added: to users, physicians and providers.]

[removed: We have] [added: This includes] three areas of focus:

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

- [removed: Build] [added: Strengthening] physician support by [removed: increasing] [added: demonstrating] the clinical evidence [removed: that demonstrates the benefits that] [added: of how] the Omnipod [removed: System provides] [added: system improves outcomes] and [removed: improving the monitoring] [added: quality of life, and providing] data [removed: available] [added: and insights] to physicians [removed: providing] [added: offering] diabetes care.

other physiological reasons.

| | | | | | |

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

Omnipod DASH was fully launched in the United States in 2019 and in our existing international markets in 2020 and 2021.

It features a secure Bluetooth enabled Pod and PDM with a color touch screen user interface supported by smartphone connectivity, nightly automatic data uploads providing users and their clinicians with cloud access to data, and enhancements for pushing software updates wirelessly to users.

In January 2022, we received clearance from the U.S. Food and Drug Administration’s (“FDA”) for the commercial distribution of Omnipod 5, which builds on our Omnipod DASH mobile platform.

Omnipod 5 includes an AID algorithm that is located on

the Pod.

The Pod integrates with a third-party continuous glucose monitor (“CGM”) to obtain glucose values.

The embedded algorithm then predicts glucose levels into the future and automatically adjusts insulin dosing intended to reduce the occurrence of blood glucose highs and lows.

The Pod is controllable by an Insulet-provided handheld device (Controller) or a user-downloaded Android app, which allows for full compatible smartphone control and currently integrates with a CGM manufactured by Dexcom, Inc. In February, we commenced a limited market release of Omnipod 5 in the U.S.

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.

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

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

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

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

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

| Canada | | | Greece | | | Norway | | | United Kingdom | | |

| Croatia | | | Iceland | | | Qatar | | | United States | | |

| Denmark | | | Israel | | | | | | | | |

The Omnipod System is also marketed to physicians.

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

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

| Distributor A | | | 10% | | | | | | 11% | | | | | | * | | |

| Distributor B | | | 12% | | | | | | 10% | | | | | | 11% | | |

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

Throughout 2021, we worked to receive FDA clearance for Omnipod 5 for individuals aged six years and older with type 1 diabetes, which was obtained in January 2022.

We have also filed for CE Mark approval of Omnipod 5.

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

Additionally, we plan to invest in a new manufacturing plant in another international location to further diversify globally and increase efficiency.

In addition, 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.

In the case

In addition, we

Moreover, there are no safe harbors for many common practices such as

*Privacy Laws.* Several states have enacted various privacy laws.

California.

Colorado and Virginia have enacted similar laws, also with effective dates in 2023.

There are two

| | | | | | | | | |

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

| Pod | | | Omnipod PDM | | | Omnipod DASH PDM | | |

Omnipod DASH, launched in the United States in 2019 and in 2020 in our international markets, features a secure Bluetooth enabled Pod and PDM with a color touch screen user interface supported by smartphone connectivity.

In addition, the updated release launched in June 2020 features an option to choose Spanish language, nightly automatic data uploads providing users and their clinicians with cloud access to data, and the ability for us to push software updates wirelessly to users.

The Omnipod System is also marketed and sold through distributors, as well as marketed to physicians and consumers.

Our products are subject to regulatory changes and competition in technological innovation, price, convenience of use, service and product performance.

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

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

| Anda, Inc. | | | | | | 11% | | | | | | * | | | | | | * | | |

| Cardinal Health Inc. and affiliates | | | | | | 10% | | | | | | 11% | | | | | | 12% | | |

| Amgen, Inc. | | | | | | * | | | | | | * | | | | | | 12% | | |

In addition, we compete with Roche Holdings Ltd. (“Roche”) and The Ypsomed Group (“Ypsomed”) outside the United States.

Omnipod 5, powered by HorizonTM Automated Insulin Delivery System (“Omnipod 5”)

We are developing an automated insulin delivery (“AID”) system that utilizes the DASH mobile platform to allow the Pod, our automated insulin delivery algorithm located on the Pod and the glucose sensor values obtained directly from a third party’s continuous glucose monitor (“CGM”) to predict glucose levels into the future and automatically adjust the insulin dose required

to help reduce the occurrence of blood glucose highs and lows.

We plan to launch Omnipod 5 with a CGM manufactured by Dexcom, Inc. and compatibility with the Android platform.

Omnipod 5 is intended to be controllable through a secure mobile app on the user’s smartphone (i.e. “phone control”).

We completed the first phase of our Omnipod 5 pivotal trial in October 2020.

In addition, we have begun enrolling individuals with Type 2 diabetes in an Omnipod 5 feasibility study.

Omnipod 5 was granted designation in the U.S. Food and Drug Administration’s (“FDA”) breakthrough device program, which is a program intended to help people have more timely access to certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions by expediting the development and review process.

We believe that recent and ongoing developments in the use of CGM technology and AID algorithms in conjunction with insulin pump therapy will continue to provide people with insulin-dependent diabetes benefits that will make insulin pump therapy an even more attractive treatment alternative to existing MDI therapy.

We completed the installation our third U.S. manufacturing line and expect to produce sellable product on this line in 2021.

Our Acton facility has the capacity to house up to four lines.

In 2020, we invested in another contract manufacturer in China allowing us to leverage our local supplier base.

may be owned exclusively by one party.

The FDA requires each manufacturer to make this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination.

In addition, in these circumstances, we may be subject to significant regulatory fines or penalties for failure to submit the requisite 510(k) or PMA application(s).

Clinical trials for a significant risk device may begin once an IDE is approved by the FDA and the appropriate IRB at each clinical trial site.

as inducing the prescription, purchase, or recommendation of the Omnipod System may be subject to scrutiny under the law.

Such a challenge could have a material adverse effect on our business, financial condition and results of operations.

Even if we are not found to have violated the law, responding to lawsuits, government investigations or enforcement actions, defending any claims raised, and paying any resulting settlement amounts would be expensive and time-consuming, and could have a material adverse effect on our reputation and business operations.

As of December 31, 2020, we had approximately 1,900 full-time employees,

representing a 41% increase over the prior year.

In 2020, 90% of our employees responded to the survey.

We supplement this anonymous survey with additional surveys throughout the year.

We have targeted recruitment programs for veterans and university students, including those of diverse backgrounds.

On June 1, 2020, we launched a new learning platform to all worldwide employees, which provides a daily professional development topic and includes a library of topics for our busy workforce.

Since the launch, through December 31, 2020, over 45,000 lessons have been consumed by employees across the globe.

The information required by this Item is provided under “Legal Proceedings” in Note [removed: 13] [added: 17] 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: 2020] [added: 2021] | | |

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: 2020] [added: 2021] was approximately [removed: $12.7] [added: $18.8] billion.

The number of shares of common stock outstanding as of February [removed: 18, 2021] [added: 17, 2022] was [removed: 66,080,324.][added: 69,217,620.]

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: 2020.][added: 2021.]

| Item 1 | | | [removed: [Business](#id101d1fa5bd94d659e900a3dbd836cf4_13)] [added: [Business](#iee3984e984b04607a7931c48e89c96c7_13)] | | | [removed: [3](#id101d1fa5bd94d659e900a3dbd836cf4_13)] [added: [3](#iee3984e984b04607a7931c48e89c96c7_13)] | | |

| Item 1A | | | [Risk [removed: Factors](#id101d1fa5bd94d659e900a3dbd836cf4_16)] [added: Factors](#iee3984e984b04607a7931c48e89c96c7_16)] | | | [removed: [16](#id101d1fa5bd94d659e900a3dbd836cf4_16)] [added: [15](#iee3984e984b04607a7931c48e89c96c7_16)] | | |

| Item 1B | | | [Unresolved Staff [removed: Comments](#id101d1fa5bd94d659e900a3dbd836cf4_19)] [added: Comments](#iee3984e984b04607a7931c48e89c96c7_19)] | | | [removed: [30](#id101d1fa5bd94d659e900a3dbd836cf4_19)] [added: [30](#iee3984e984b04607a7931c48e89c96c7_19)] | | |

| Item 2 | | | [removed: [Properties](#id101d1fa5bd94d659e900a3dbd836cf4_22)] [added: [Properties](#iee3984e984b04607a7931c48e89c96c7_22)] | | | [removed: [30](#id101d1fa5bd94d659e900a3dbd836cf4_22)] [added: [30](#iee3984e984b04607a7931c48e89c96c7_22)] | | |

| Item 3 | | | [Legal [removed: Proceedings](#id101d1fa5bd94d659e900a3dbd836cf4_25)] [added: Proceedings](#iee3984e984b04607a7931c48e89c96c7_25)] | | | [removed: [30](#id101d1fa5bd94d659e900a3dbd836cf4_25)] [added: [30](#iee3984e984b04607a7931c48e89c96c7_25)] | | |

| Item 4 | | | [Mine Safety [removed: Disclosures](#id101d1fa5bd94d659e900a3dbd836cf4_28)] [added: Disclosures](#iee3984e984b04607a7931c48e89c96c7_28)] | | | [removed: [30](#id101d1fa5bd94d659e900a3dbd836cf4_28)] [added: [30](#iee3984e984b04607a7931c48e89c96c7_28)] | | |

| Item 5 | | | [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#id101d1fa5bd94d659e900a3dbd836cf4_34)] [added: Securities](#iee3984e984b04607a7931c48e89c96c7_34)] | | | [removed: [31](#id101d1fa5bd94d659e900a3dbd836cf4_34)] [added: [31](#iee3984e984b04607a7931c48e89c96c7_34)] | | |

| Item 7 | | | [Management's Discussion and Analysis of Financial Condition and Results of [removed: Operations](#id101d1fa5bd94d659e900a3dbd836cf4_40)] [added: Operations](#iee3984e984b04607a7931c48e89c96c7_40)] | | | [removed: [32](#id101d1fa5bd94d659e900a3dbd836cf4_40)] [added: [33](#iee3984e984b04607a7931c48e89c96c7_40)] | | |

| Item 7A | | | [Quantitative and Qualitative Disclosures About Market [removed: Risk](#id101d1fa5bd94d659e900a3dbd836cf4_64)] [added: Risk](#iee3984e984b04607a7931c48e89c96c7_64)] | | | [removed: [39](#id101d1fa5bd94d659e900a3dbd836cf4_64)] [added: [40](#iee3984e984b04607a7931c48e89c96c7_64)] | | |

| Item 8 | | | [Financial Statements and Supplementary [removed: Data](#id101d1fa5bd94d659e900a3dbd836cf4_67)] [added: Data](#iee3984e984b04607a7931c48e89c96c7_67)] | | | [removed: [40](#id101d1fa5bd94d659e900a3dbd836cf4_67)] [added: [41](#iee3984e984b04607a7931c48e89c96c7_67)] | | |

| Item 9 | | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#id101d1fa5bd94d659e900a3dbd836cf4_181)] [added: Disclosure](#iee3984e984b04607a7931c48e89c96c7_157)] | | | [removed: [70](#id101d1fa5bd94d659e900a3dbd836cf4_181)] [added: [71](#iee3984e984b04607a7931c48e89c96c7_157)] | | |

| Item 9A | | | [Controls and [removed: Procedures](#id101d1fa5bd94d659e900a3dbd836cf4_184)] [added: Procedures](#iee3984e984b04607a7931c48e89c96c7_160)] | | | [removed: [70](#id101d1fa5bd94d659e900a3dbd836cf4_184)] [added: [71](#iee3984e984b04607a7931c48e89c96c7_160)] | | |

| Item 9B | | | [Other [removed: Information](#id101d1fa5bd94d659e900a3dbd836cf4_187)] [added: Information](#iee3984e984b04607a7931c48e89c96c7_163)] | | | [removed: [70](#id101d1fa5bd94d659e900a3dbd836cf4_187)] [added: [71](#iee3984e984b04607a7931c48e89c96c7_163)] | | |

| Item 10 | | | [Directors, Executive Officers and Corporate [removed: Governance](#id101d1fa5bd94d659e900a3dbd836cf4_193)] [added: Governance](#iee3984e984b04607a7931c48e89c96c7_169)] | | | [removed: [70](#id101d1fa5bd94d659e900a3dbd836cf4_193)] [added: [71](#iee3984e984b04607a7931c48e89c96c7_169)] | | |

| Item 11 | | | [Executive [removed: Compensation](#id101d1fa5bd94d659e900a3dbd836cf4_196)] [added: Compensation](#iee3984e984b04607a7931c48e89c96c7_172)] | | | [removed: [70](#id101d1fa5bd94d659e900a3dbd836cf4_196)] [added: [71](#iee3984e984b04607a7931c48e89c96c7_172)] | | |

| Item 12 | | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#id101d1fa5bd94d659e900a3dbd836cf4_199)] [added: Matters](#iee3984e984b04607a7931c48e89c96c7_175)] | | | [removed: [71](#id101d1fa5bd94d659e900a3dbd836cf4_199)] [added: [72](#iee3984e984b04607a7931c48e89c96c7_175)] | | |

| Item 13 | | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#id101d1fa5bd94d659e900a3dbd836cf4_202)] [added: Independence](#iee3984e984b04607a7931c48e89c96c7_178)] | | | [removed: [71](#id101d1fa5bd94d659e900a3dbd836cf4_202)] [added: [72](#iee3984e984b04607a7931c48e89c96c7_178)] | | |

| Item 14 | | | [Principal Accounting Fees and [removed: Services](#id101d1fa5bd94d659e900a3dbd836cf4_205)] [added: Services](#iee3984e984b04607a7931c48e89c96c7_181)] | | | [removed: [71](#id101d1fa5bd94d659e900a3dbd836cf4_205)] [added: [72](#iee3984e984b04607a7931c48e89c96c7_181)] | | |

| Item 15 | | | [Exhibits, Financial Statement [removed: Schedules](#id101d1fa5bd94d659e900a3dbd836cf4_211)] [added: Schedules](#iee3984e984b04607a7931c48e89c96c7_187)] | | | [removed: [72](#id101d1fa5bd94d659e900a3dbd836cf4_211)] [added: [73](#iee3984e984b04607a7931c48e89c96c7_187)] | | |

| Item 16 | | | [Form 10-K [removed: Summary](#id101d1fa5bd94d659e900a3dbd836cf4_214)] [added: Summary](#iee3984e984b04607a7931c48e89c96c7_190)] | | | [removed: [75](#id101d1fa5bd94d659e900a3dbd836cf4_214)] [added: [76](#iee3984e984b04607a7931c48e89c96c7_190)] | | |

| [PART I](#iee3984e984b04607a7931c48e89c96c7_10) | | | | | | | | |

| [PART II](#iee3984e984b04607a7931c48e89c96c7_166) | | | | | | | | |

| Item 6 | | | [Reserved](#iee3984e984b04607a7931c48e89c96c7_37) | | | [32](#iee3984e984b04607a7931c48e89c96c7_37) | | |

| [PART II](#iee3984e984b04607a7931c48e89c96c7_166)I | | | | | | | | |

| [PART I](#iee3984e984b04607a7931c48e89c96c7_166)V | | | | | | | | |

| | | | [SIGNATURES](#iee3984e984b04607a7931c48e89c96c7_193) | | | [77](#iee3984e984b04607a7931c48e89c96c7_193) | | |

| [PART I](#id101d1fa5bd94d659e900a3dbd836cf4_10) | | | | | | | | |

| [PART II](#id101d1fa5bd94d659e900a3dbd836cf4_190) | | | | | | | | |

| Item 6 | | | [Selected Financial Data](#id101d1fa5bd94d659e900a3dbd836cf4_37) | | | [31](#id101d1fa5bd94d659e900a3dbd836cf4_37) | | |

| [PART II](#id101d1fa5bd94d659e900a3dbd836cf4_190)I | | | | | | | | |

| [PART I](#id101d1fa5bd94d659e900a3dbd836cf4_190)V | | | | | | | | |

| | | | [SIGNATURES](#id101d1fa5bd94d659e900a3dbd836cf4_217) | | | [76](#id101d1fa5bd94d659e900a3dbd836cf4_217) | | |

As of December 31, [removed: 2020,] [added: 2021,] we leased a total of [removed: 15] [added: 17] facilities in [removed: 7] [added: 8] countries consisting of approximately [removed: 225,000] [added: 320,000] square feet of office, research and [removed: development] [added: development,] and warehousing space and other related facilities, primarily in North [removed: America] [added: America, Asia] and Europe.

As of February [removed: 18, 2021,] [added: 17, 2022,] there were 8 registered holders of record of our common stock.

[removed: Performance] [added: Stock Performance] Graph

The following graph shows the cumulative total return on $100 invested in each of our common stock, the NASDAQ Composite Index and the NASDAQ Health Care Index for the five-year period beginning on December 31, [removed: 2015,] [added: 2016,] and ending on December 31, [removed: 2020,] [added: 2021,] assuming reinvestment of all dividends.

[removed: ][added: ]

| | | | [removed: 2015 | | |] 2016 | | | 2017 | | | 2018 | | | 2019 | | | 2020 | | | [added: 2021 | | |]

Market Information

Holders of Record

Recent Sales of Unregistered Securities

During the year ended December 31, 2021, we issued securities that were not registered under the Securities Act, which were issued in reliance on the exemption from registration under Section 3(a)(9) of the Securities Act of 1933, as amended (the “Securities Act”).

We issued 2,586,133 shares of our common stock to certain holders of our 1.375% Convertible Senior Notes due 2024 (the “Notes”) upon the conversion of $402.5 million aggregate principal amount of the Notes by such holders.

| Insulet Corporation | | | $ | 100 | | $ | 183 | | $ | 211 | | $ | 454 | | $ | 678 | | $ | 706 | |

| NASDAQ Composite | | | $ | 100 | | $ | 128 | | $ | 123 | | $ | 167 | | $ | 239 | | $ | 291 | |

| NASDAQ Health Care | | | $ | 100 | | $ | 121 | | $ | 116 | | $ | 146 | | $ | 190 | | $ | 183 | |

Securities Authorized for Issuance Under Equity Compensation Plans

The information required by this Item is provided under Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

MARKET FOR REGISTRANT’S COMMON EQUITY

| Insulet Corporation | | | $ | 100 | | $ | 100 | | $ | 182 | | $ | 210 | | $ | 453 | | $ | 676 | |

| NASDAQ Composite | | | $ | 100 | | $ | 108 | | $ | 138 | | $ | 138 | | $ | 179 | | $ | 257 | |

| NASDAQ Health Care | | | $ | 100 | | $ | 83 | | $ | 101 | | $ | 97 | | $ | 122 | | $ | 158 | |

Consistent with the amendments to Regulation S-K, we are not required to disclose information previously required by this item.

Our financial statements as of December 31, [removed: 2020] [added: 2021] and [removed: 2019] [added: 2020] and for each of the three years in the period ended December 31, [removed: 2020,] [added: 2021,] 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](#id101d1fa5bd94d659e900a3dbd836cf4_70)] [added: Firm](#iee3984e984b04607a7931c48e89c96c7_70) (PCAOB ID Number 248)] | | | [removed: [41](#id101d1fa5bd94d659e900a3dbd836cf4_70)] [added: [42](#iee3984e984b04607a7931c48e89c96c7_70)] | | |

| Consolidated Balance Sheets as of December 31, [removed: 2020] [added: 2021] and [removed: 2019] [added: 2020] | | | [removed: [43](#id101d1fa5bd94d659e900a3dbd836cf4_73)] [added: [44](#iee3984e984b04607a7931c48e89c96c7_73)] | | |

| Consolidated Statements of Income for the Years ended December 31, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018] [added: 2019] | | | [removed: [44](#id101d1fa5bd94d659e900a3dbd836cf4_79)] [added: [45](#iee3984e984b04607a7931c48e89c96c7_76)] | | |

| [Consolidated Statements of Comprehensive [removed: I](#id101d1fa5bd94d659e900a3dbd836cf4_82)ncome] [added: I](#iee3984e984b04607a7931c48e89c96c7_79)ncome] for the Years [removed: Ended] [added: ended] December 31, [removed: 2020, 2019] [added: 2021, 2020] and [removed: 2018] [added: 2019] | | | [removed: [45](#id101d1fa5bd94d659e900a3dbd836cf4_82)] [added: [46](#iee3984e984b04607a7931c48e89c96c7_79)] | | |

| [Consolidated Statements of Stockholders’ Equity for the Years ended December [removed: 31,](#id101d1fa5bd94d659e900a3dbd836cf4_85) 2020, 2019] [added: 31,](#iee3984e984b04607a7931c48e89c96c7_82) 2021, 2020] and [removed: 2018] [added: 2019] | | | [removed: [46](#id101d1fa5bd94d659e900a3dbd836cf4_85)] [added: [47](#iee3984e984b04607a7931c48e89c96c7_82)] | | |

| [Consolidated Statements of Cash Flows for the Years ended December [removed: 31,](#id101d1fa5bd94d659e900a3dbd836cf4_91) 2020, 2019] [added: 31,](#iee3984e984b04607a7931c48e89c96c7_85) 2021, 2020] and [removed: 2018] [added: 2019] | | | [removed: [47](#id101d1fa5bd94d659e900a3dbd836cf4_91)] [added: [48](#iee3984e984b04607a7931c48e89c96c7_85)] | | |

| [Notes to Consolidated Financial [removed: Statements](#id101d1fa5bd94d659e900a3dbd836cf4_94)] [added: Statements](#iee3984e984b04607a7931c48e89c96c7_88)] | | | [removed: [48](#id101d1fa5bd94d659e900a3dbd836cf4_94)] [added: [49](#iee3984e984b04607a7931c48e89c96c7_88)] | | |

We have audited the accompanying consolidated balance sheets of Insulet Corporation (a Delaware corporation) and subsidiaries (the “Company”) as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] and the related consolidated statements of income, comprehensive income, changes in stockholders’ equity, and cash flows for each of the three years in the period ended December 31, [removed: 2020,] [added: 2021,] and the related notes and financial statement [removed: schedules] [added: schedule] included under Item 15(a) (collectively referred to as the “financial statements”).

We also have audited the Company’s internal control over financial reporting as of December 31, [removed: 2020,] [added: 2021,] 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 (“COSO”).

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, [removed: 2020] [added: 2021] and [removed: 2019,] [added: 2020,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2020] [added: 2021] in conformity with accounting principles generally accepted in the United States of America.

[removed: Also] [added: Also,] in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2020,] [added: 2021,] based on criteria established in the 2013 Internal Control*—*Integrated Framework issued by COSO.

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

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

The principal considerations for our determination that this matter is a critical audit matter are [removed: as follows:][added: the application of the accounting guidance for cash paid to note holders and the estimation of fair value of the debt component of the notes.]

| (in millions, except share and per share data) | | | [added: 2021 | | | | | |] 2020 | | | | | | 2019 | | |

| Cash and cash equivalents | | | $ | [removed: 907.2] [added: 791.6] | | | | | $ | [removed: 213.7] [added: 907.2] | |

| Short-term investments | | | [removed: 40.4] [added: —] | | | | | | [removed: 162.4] [added: 40.4] | | |

| Accounts receivable trade, net | | | [removed: 83.8] [added: $] | [added: 127.0] | | | | | [removed: 69.3] [added: $] | [added: 83.8] | |

| Inventories | | | [removed: 154.3] [added: 303.2] | | | | | | [removed: 101.0] [added: 154.3] | | |

| Prepaid expenses and other current assets | | | [removed: 63.0] [added: 74.0] | | | | | | [removed: 44.6] [added: 51.5] | | |

| Total current assets | | | [removed: 1,248.7] [added: 1,329.8] | | | | | | [removed: 591.0] [added: 1,248.7] | | |

| Property, plant and equipment, net | | | [removed: 478.7] [added: 536.5] | | | | | | [removed: 399.4] [added: 478.7] | | |

| Other intangible assets, net | | | [removed: 28.7] [added: 36.6] | | | | | | [removed: 13.2] [added: 28.7] | | |

| Other assets | | | [removed: 77.0] [added: 106.1] | | | | | | [removed: 41.1] [added: 77.0] | | |

| Total assets | | | $ | [removed: 1,872.9] [added: 2,048.8] | | | | | $ | [removed: 1,142.9] [added: 1,872.9] | |

| Accounts payable | | | $ | [removed: 54.1] [added: 37.7] | | | | | $ | [removed: 54.5] [added: 54.1] | |

| [removed: Accrued] [added: Accrued] expenses and other current [removed: liabilities] [added: liabilities] | | | [removed: 138.1] [added: $] | [added: 166.0] | | | | | [removed: 103.2] [added: $] | [added: 138.1] | |

| Current portion of long-term debt | | | [removed: 15.6] [added: 25.1] | | | | | | [removed: —] [added: 15.6] | | |

| Total current liabilities | | | [removed: 207.8] [added: 228.8] | | | | | | [removed: 157.7] [added: 207.8] | | |

| Long-term debt, net | | | [removed: 1,043.7] [added: 1,248.8] | | | | | | [removed: 887.9] [added: 1,043.7] | | |

| Other liabilities | | | [removed: 17.8] [added: 14.9] | | | | | | [removed: 21.4] [added: 17.8] | | |

| Total liabilities | | | [removed: 1,269.3] [added: 1,492.5] | | | | | | [removed: 1,067.0] [added: 1,269.3] | | |

| Commitment and Contingencies (Note [removed: 13)] [added: 17)] | | | | | | | | | | | |

| Authorized: 5,000,000 shares at December 31, [removed: 2020] [added: 2021] and [removed: 2019.] [added: 2020] Issued and outstanding: zero shares at December 31, [removed: 2020] [added: 2021] and [removed: 2019.] [added: 2020] | | | — | | | | | | — | | |

| Authorized: 100,000,000 shares at December 31, [removed: 2020] [added: 2021] and [removed: 2019.] [added: 2020] Issued and outstanding: [removed: 66,017] [added: 69,178,691] and [removed: 62,685] [added: 66,017,444] shares at December 31, [removed: 2020] [added: 2021] and [removed: 2019] [added: 2020] | | | 0.1 | | | | | | 0.1 | | |

| Additional paid-in capital | | | [removed: 1,264.3] [added: 1,207.9] | | | | | | [removed: 749.0] [added: 1,264.3] | | |

| Accumulated deficit | | | [removed: (666.3)] [added: (649.5)] | | | | | | [removed: (672.0)] [added: (666.3)] | | |

| Accumulated other comprehensive [removed: income] (loss) [added: income] | | | [removed: 5.5] [added: (2.2)] | | | | | | [removed: (1.2)] [added: 5.5] | | |

| Total stockholders’ equity | | | [removed: 603.6] [added: 556.3] | | | | | | [removed: 75.9] [added: 603.6] | | |

*Convertible Debt Repurchase and Conversion*

As described further in Note 15 to the consolidated financial statements, the Company repurchased and converted its 1.375% Convertible Senior Notes (“the notes”) due November 2024 for cash and the issuance of common stock.

This resulted in a total loss on extinguishment of $42.4 million.

We identified this transaction as a critical audit matter.

The guidance for accounting for the inducement as a debt extinguishment is complex.

The Company estimated the fair value of the debt component to determine the loss on extinguishment using a yield model that includes several assumptions, including the discount rate.

- We tested the design and operating effectiveness of controls related to management’s accounting and valuation for the repurchase transaction including management’s evaluation of the qualifications of specialists and review of the work performed by the specialists.

- We consulted with our national office resources regarding management’s accounting conclusion that the repurchase of the notes be accounted for as an extinguishment of debt.

- With the assistance of valuation professionals with specialized skills and knowledge, we tested management’s fair value of the debt component of the notes.

This included an assessment of the appropriateness of the methodology, inputs and key assumptions used.

February 23, 2022

| Accounts receivable, net (Related Party Transactions Note 5) | | | 161.0 | | | | | | 95.3 | | |

| Revenue (Related Party Transactions Note 5) | | | $ | 1,098.8 | | | | | $ | 904.4 | | | | | $ | 738.2 | |

| Unrealized gain on cash flow hedges | | | 4.5 | | | | | | — | | | | | | — | | |

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

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

| Net income | | | $ | 16.8 | | | | | $ | 6.8 | | | | | $ | 11.6 | |

| Accounts receivable | | | (71.3) | | | | | | (13.7) | | | | | | (10.9) | | |

| Proceeds from issuance of term loan, net of issuance costs | | | 489.5 | | | | | | — | | | | | | — | | |

| Repayment of term loan | | | (2.5) | | | | | | — | | | | | | — | | |

| Repayment of equipment financings | | | (17.8) | | | | | | (1.4) | | | | | | — | | |

| Repayment of mortgage | | | (2.0) | | | | | | (0.3) | | | | | | — | | |

| Payment of debt issuance costs | | | (4.0) | | | | | | (0.5) | | | | | | — | | |

| Proceeds from exercise of stock options | | | 15.4 | | | | | | 25.7 | | | | | | 46.6 | | |

| Purchases of intangible assets included in accounts payable and accrued expenses | | | $ | 3.2 | | | | | $ | — | | | | | $ | 0.5 | |

| Lease liabilities arising from obtaining right-of-use assets | | | $ | 0.7 | | | | | $ | 2.5 | | | | | $ | 9.8 | |

Unbilled revenues have been combined with accounts receivable, net on the consolidated balance sheet.

The impact of this change was an increase to accounts receivable, net and a decrease to prepaid expenses and other current assets at December 31, 2020.

Unbilled revenue is presented in Note 8.

In addition, the Company reclassified the change in unbilled receivables from the change in prepaid expenses and other current assets to the change in accounts receivable in the prior year statements of cash flows in the amount of $1.9 million and $0.1 million for the years ended December 31, 2020 and 2019, respectively.

bonds that are carried at cost, which approximates their fair value.

Derivative Instruments

The Company is exposed to certain risks relating to its business operations.

Risks that relate to interest rate exposure are managed by using interest rate swaps.

The Company recognizes derivative instruments as either assets or liabilities at fair value

Changes in a derivative financial instrument’s fair value are recognized in earnings unless specific hedge criteria are met, in which case changes in fair value are recognized as adjustments to other comprehensive income.

The Company has designated its interest rate swap contracts as cash flow hedges.

The Company assesses the recoverability of capitalized implementation costs in accordance with the policy disclosed under *Property, Plant and Equipment*.

At the outset of the contract, the Company assesses the customer’s ability and intention to pay, which is based on a

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

are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.

*Revenue Recognition - Drug Delivery*

As described in Note 4 to the consolidated financial statements, the Company’s revenue from drug delivery was $69.5 million for the year ended December 31, 2020.

Drug delivery revenue is recognized over time based on the Company’s determination of the pattern over which control transfers to the customer.

This transfer of control begins during the manufacturing process and continues through the final quality control inspection process until there is complete satisfaction of the performance obligation.

We identified drug delivery revenue recognition and the associated unbilled receivable as a critical audit matter.

Accounting for drug delivery revenue requires the Company to select a method to measure progress towards the satisfaction of the performance obligation.

This election of the most meaningful measure of progress by which to recognize drug delivery revenue requires the application of significant management judgment.

The Company elected the input method and selected a blend of cost and time to produce for measure of progress.

Given the nature of the revenue being recognized, additional audit effort including modification of the nature and extent of our procedures beyond that of the Company’s other revenue streams was required.

- We tested the design and operating effectiveness of controls relating to Management’s estimate of the measure of progress.

- For the measure of progress, we inspected evidence related to the cost and length of the production cycle.

- For revenue recognized on in-process or finished goods inventory (and the related unbilled receivable), we inspected customer orders, binding customer forecasts, inventory records, and third party shipping documentation.

February 23, 2021

| Long-term investments | | | — | | | | | | 58.4 | | |

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

| Balance, December 31, 2017 | | | 58,319 | | | | | | $ | 0.1 | | | | | $ | 866.2 | | | | | $ | (707.3) | | | | | $ | (0.5) | | | | | $ | 158.5 | |

| Adoption of ASC 606 (Note 2) | | | — | | | | | | — | | | | | | — | | | | | | 20.4 | | | | | | — | | | | | | 20.4 | | |

| Other | | | (2.2) | | | | | | — | | | | | | — | | |

A portion of facility costs and certain information technology costs have been allocated from selling, general and administrative to research and development expenses based on square foot and system usage, respectively and certain quality assurance costs were reclassified from research and development expenses to selling, general and administrative expenses.

The net impact of these adjustments was a $2.6 million and $4.3 million increase to research and development expenses and decrease to selling, general and administrative expenses for the years ended December 31, 2019 and December 31, 2018, respectively.

Restricted cash required to be set aside in connection with

Work in process is calculated based upon a buildup of cost based on the stage of production.

Manufacturing variances attributable to abnormally low production are expensed in the period incurred.

When estimating fair value, the Company may use one or all the following approaches:

- Market approach, which is based on market prices and other information from market transactions involving identical or comparable assets or liabilities.

- Cost approach, which is based on the cost to acquire or construct comparable assets less an allowance for functional and/or economic obsolescence.

- Income approach, which is based on the present value of the future stream of net cash flows.

In performing the quantitative test, the Company utilizes a two-step approach.

If the reporting unit’s carrying value exceeds its fair value, the Company would perform the second step and record an impairment loss to the extent that the carrying value of the reporting unit’s goodwill exceeds its implied fair value.

Intangible assets with finite useful lives

As of December 31, 2020 and 2019, the Company had net capitalized implementation costs of $24.2 million and $3.5 million, respectively.

Effective January 1, 2018, the Company adopted ASU 2014-09, *Revenue from Contracts with Customers,* and its related amendments (collectively referred to as ASC 606) using the modified retrospective method for all contracts not completed as of the date of adoption.

The cumulate effect of applying the new revenue standard resulted in a $20.4 million decrease to the opening balance of accumulated deficit upon adoption, primarily related to how revenue is recognized for the Company’s drug delivery product line and the capitalization of contract acquisition costs such as commissions.

The amount of stock-based

In addition to manufacturing the Omnipod System, the Company also purchases Omnipod Systems from two contract manufacturers.

As of December 31, 2020, neither of these vendors represented 10% or more of the combined balance of accounts payable and accrued expenses and other current liabilities.

As of December 31, 2019, one of these vendors represented 10% of the combined balance of accounts payable and accrued expenses and other current liabilities.

ASU 2016-13 requires financial assets measured at amortized cost, such as the Company’s trade receivables and contract assets, to be presented net of expected credit losses, which may be estimated based on relevant information such as historical experience, current conditions and future expectation for each pool of similar financial assets.

The new guidance also requires enhanced disclosures related to trade receivables and associated credit losses.

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: 2020.][added: 2021.]

Based on the evaluation of our disclosure controls and procedures as of December 31, [removed: 2020,] [added: 2021,] our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at a reasonable assurance level.

There were no changes in our internal control over financial reporting during the three months ended December 31, [removed: 2020] [added: 2021] 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: 2020.][added: 2021.]

Based on our assessment, we believe that our internal controls over financial reporting were effective as of December 31, [removed: 2020.][added: 2021.]

The effectiveness of our internal control over financial reporting as of December 31, [removed: 2020] [added: 2021] has been audited by Grant Thornton LLP, an independent registered public accounting firm.

The information required by this Item will be set forth in our definitive proxy statement for our [removed: 2021] [added: 2022] 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: 2020.][added: 2021.]

| Equity compensation plans [added: not] approved by security holders [removed: (1)] | | | [removed: 966,052] [added: —] | | | | | | $ | [removed: 60.79] [added: —] | | | | | [removed: 3,624,340] [added: —] | | | [removed: (2)] | | |

| Equity compensation plans [removed: not] approved by security holders [removed: (3)] [added: (1)] | | | [removed: 112,436] [added: 765,457] | | | | | | $ | [removed: 33.90] [added: 81.98] | | | | | [removed: —] [added: 3,249,369] | | | [added: (2)] | | |

As of December 31, [removed: 2020, 489,776] [added: 2021, 384,155] 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: $60.79.][added: $81.98.]

For more information relating to our equity compensation plans, see Note [removed: 14] [added: 18] to our consolidated financial statements.

| Total | | | 765,457 | | | | | | $ | 81.98 | | | | | 3,249,369 | | | | | |

| Total | | | 1,078,488 | | | | | | $ | 57.99 | | | | | 3,624,340 | | | | | |

(3) Consists of the following inducement grants made to certain executive officers upon their initial hire by the Company:

- one inducement grant of 499,468 shares of non-qualified stock option awards made to the Company’s former CEO Patrick J.

Sullivan in September 2014 (439,468 of which have been exercised as of December 31, 2020); and

- one inducement grant of 79,936 non-qualified stock options made to Shacey Petrovic upon being hired by us in February 2015 (27,500 of which have been exercised as of December 31, 2020)

These non-qualified stock option awards were granted outside of our Amended and Restated 2007 Stock Option and Incentive Plan in compliance with Nasdaq Listing Rule 5635.

| 4.2 | | | [Indenture, dated as of November 10, 2017, between Insulet Corporation and Wells Fargo Bank, National Association, as Trustee (Incorporated by [removed: reference] [added: r](https://www.sec.gov/Archives/edgar/data/1145197/000119312517340998/d492303dex41.htm)[e](https://www.sec.gov/Archives/edgar/data/1145197/000119312517340998/d492303dex41.htm)[ference] to Exhibit 4.1 to our Current Report on Form 8-K, filed on November 13, [removed: 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000119312517340998/d492303dex41.htm)] [added: 2017)](https://www.sec.gov/Archives/edgar/data/1145197/000119312517340998/d492303dex41.htm)] | | |

| 4.3 | | | [Form of 1.375% Convertible Senior Notes due 2024 (included in Exhibit [removed: 4.2)](http://www.sec.gov/Archives/edgar/data/1145197/000119312517340998/d492303dex41.htm)] [added: 4.2)](https://www.sec.gov/Archives/edgar/data/1145197/000119312517340998/d492303dex41.htm)] | | |

| 10.9* | | | [Form of [removed: Vice President Restricted] [added: Executive Officer 3 Year Incentive] Stock [removed: Unit] [added: Option] Agreement [removed: with Performance Component] under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit [removed: 10.1] [added: 10.7] to our Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2017, filed May 9, [removed: 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000009/podd-exx101_2017331x10q.htm)] [added: 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000009/podd-exx107_2017331x10q.htm)] | | |

| [removed: 10.10*] [added: 10.15*] | | | [Form of [removed: Employee Restricted] [added: Incentive] Stock [removed: Unit] [added: Option] Agreement [removed: with Performance Component] under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit [removed: 10.2] [added: 10.4] to our Quarterly Report on Form 10-Q for the fiscal quarter ended [removed: March 31, 2017,] [added: June 30, 2015,] filed [removed: May 9, 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000009/podd-exx102_2017331x10q.htm)] [added: August 12, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000059/podd-ex104_20150630x10q.htm)] | | |

| 10.11* | | | [Form of [removed: Executive Officer 3 Year Performance Vesting Restricted] [added: Non-Qualified] Stock [removed: Unit] [added: Option] Agreement [added: for Non-Employee Directors] under the [removed: Insulet Corporation] Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.3 to our Quarterly Report on Form 10-Q for the fiscal quarter ended [removed: March 31, 2017,] [added: June 30, 2016,] filed [removed: May 9, 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000009/podd-exx103_201733110q.htm)] [added: August 4, 2016](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000094/podd-exx103_20160630x10q.htm))] | | |

| [removed: 10.12*] [added: 10.14*] | | | [Form of Vice President [removed: 3 Year Performance Vesting Restricted] [added: Incentive] Stock [removed: Unit] [added: Option] Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit [removed: 10.4] [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-exx104_2017331x10q.htm)] [added: February 29, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1064_20151231x10k.htm)] | | |

| 10.13* | | | [Form of [removed: Executive] [added: Section 16] Officer [removed: Cliff Vesting Performance Restricted] [added: Incentive] Stock [removed: Unit] [added: Option] Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit [removed: 10.5] [added: 10.62] 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-exx105_2017331x10q.htm)] [added: February 29, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1062_20151231x10k.htm)] | | |

| [removed: 10.14*] [added: 10.10*] | | | [Form of International [removed: 3 Year Vesting Restricted] [added: Non-Qualified] Stock [removed: Unit] [added: Option] Agreement under the [removed: Insulet Corporation] Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit [removed: 10.6] [added: 10.1] to our Quarterly Report on Form 10-Q for the fiscal quarter ended [removed: March 31, 2017,] [added: June 30, 2016,] filed [removed: May 9, 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000009/podd-exx106_201733110q.htm)] [added: August 4, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000094/podd-exx101_20160630x10q.htm)] | | |

| [removed: 10.15*] [added: 10.21*] | | | [Form of [removed: Executive Officer 3 Year] 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 10.7 to our Quarterly Report on Form 10-Q for the fiscal quarter ended [removed: March 31, 2017,] [added: September 30, 2014,] filed [removed: May 9, 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000009/podd-exx107_2017331x10q.htm)] [added: November 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex107_20140930x10q.htm)] | | |

| [removed: 10.16*] [added: 10.19*] | | | [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: 10.17*] [added: 10.20*] | | | [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: 10.18*] [added: 10.22*] | | | [Form of [removed: Vice President] Incentive Stock Option Agreement [removed: (Three Year Vest)] [added: for Section 16 Officers] under the [removed: Third] [added: Second] Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit [removed: 10.4] [added: 10.10] 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-exx104_20160630x10q.htm)] [added: November 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex1010_20140930x10q.htm)] | | |

| [removed: 10.19*] [added: 10.12*] | | | [Form of Non-Executive Employee [removed: Time Vesting Restricted] [added: Incentive] Stock [removed: Unit] [added: Option] Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit [removed: 10.59] [added: 10.60] to our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed February 29, [removed: 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1059_20151231x10k.htm)] [added: 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1060_20151231x10k.htm)] | | |

| [removed: 10.20*] [added: 10.16*] | | | [Form of [removed: Non-Executive Employee] 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: 10.60] [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-exx1060_20151231x10k.htm)] [added: 26, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000020/poddex1051_2014311210k.htm)] | | |

| [removed: 10.21*] [added: 10.17*] | | | [Form of [removed: Section 16 Officer Time Vesting Restricted] [added: Non-Qualified] Stock [removed: Unit] [added: Option] Agreement [added: for Shacey Petrovic] under the [removed: Insulet Corporation Third] [added: Second] Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit [removed: 10.61] [added: 10.53] 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-exx1061_20151231x10k.htm)] [added: 26, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000020/poddex1053_2014123110k.htm)] | | |

| [removed: 10.22*] [added: 10.18*] | | | [Form of [removed: Section 16 Officer Incentive] [added: UK Non-Qualified] Stock Option Agreement [added: for Employees at the Vice President Level and Above] under the [removed: Insulet Corporation Third] [added: Second] Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit [removed: 10.62] [added: 10.56] 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-exx1062_20151231x10k.htm)] [added: 26, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000020/poddex1056_2014123110k.htm)] | | |

| 10.23* | | | [Form of [removed: Vice President Time Vesting Restricted] [added: Non-Qualified] Stock [removed: Unit] [added: Option] Agreement [added: for Section 16 Officers] under the [removed: Insulet Corporation Third] [added: Second] Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit [removed: 10.63] [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, 2015,] [added: September 30, 2014,] filed [removed: February 29, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1063_20151231x10k.htm)] [added: November 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex1011_20140930x10q.htm)] | | |

| 10.24* | | | [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: - October 2014 New Hires] (Incorporated by reference to Exhibit [removed: 10.64] [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, 2015,] [added: September 30, 2014,] filed [removed: February 29, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1064_20151231x10k.htm)] [added: November 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd_ex1015x20140903-10q.htm)] | | |

| [removed: 10.25*] [added: 10.31+] | | | [removed: [Form of Canada Non-Qualified Stock Option] [added: [Materials Supplier] Agreement [removed: for Company Employees under the] [added: between] Insulet Corporation [removed: Second Amended] and [removed: Restated 2007 Stock Option] [added: Flextronics Medical Sales] and [removed: Incentive Plan] [added: Marketing, Ltd, dated September 1, 2016] (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, [removed: 2015,] [added: 2016,] filed [removed: August 12, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000059/podd-ex101_20150630x10q.htm)] [added: November 4, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000100/podd-exx101_2016930x10q.htm)] | | |

| [removed: 10.26*] [added: 10.34+] | | | [removed: [Form of Canada Time Vesting Restricted Stock Unit] [added: [Master Equipment and Services] Agreement [removed: under the] [added: between] Insulet Corporation [removed: Second Amended] and [removed: Restated 2007 Stock Option and Incentive Plan] [added: 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 [removed: June] [added: September] 30, [removed: 2015,] [added: 2016,] filed [removed: August 12, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000059/podd-ex102_20150630x10q.htm)] [added: November 4, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000100/podd-exx102_2016930x10q.htm)] | | |

| 10.27* | | | [removed: [Form of Incentive Stock Option Agreement under the Insulet] [added: [Insulet] Corporation [removed: Third Amended and Restated 2007] [added: Employee] Stock [removed: Option and Incentive] [added: Purchase] Plan [added: (Amended and Restated February 27, 2019)] (Incorporated by reference to Exhibit [removed: 10.4] [added: 10.1] to our [removed: Quarterly] [added: Current] Report on Form [removed: 10-Q for the fiscal quarter ended June 30, 2015,] [added: 8-K] filed [removed: August 12, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000059/podd-ex104_20150630x10q.htm)] [added: May 30, 2019)](http://www.sec.gov/Archives/edgar/data/1145197/000114519719000023/insuletcorporationemployee.htm)] | | |

| [removed: 10.28*] [added: 10.36+] | | | [removed: [Form of Incentive Stock Option Agreement under the Second Amended and Restated 2007 Stock Option] [added: [Supply Agreement, dated November 21, 2013, between Amgen] and [removed: Incentive Plan - 2015 Sales Plan] [added: Insulet Corporation, as amended by Amendment No. 1 through Amendment No. 14] (Incorporated by reference to Exhibit [removed: 10.51] [added: 10.18] to our Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2014,] [added: 2016,] filed February [removed: 26, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000020/poddex1051_2014311210k.htm)] [added: 28, 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000005/podd-exx1018_20161231x10k.htm)] | | |

| [removed: 10.31*] [added: 10.33+] | | | [removed: [Form of Non-Qualified Stock Option Agreement for Patrick J. Sullivan under] [added: [Settlement and Cross-License Agreement, dated September 18, 2013, by and among] the [removed: Second Amended] [added: Company] and [removed: Restated 2007 Stock Option] [added: Medtronic Inc., Medtronic MiniMed Inc.,] and [removed: Incentive Plan] [added: Medtronic Puerto Rico Operations Co.] (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, [removed: 2014,] [added: 2013,] filed November [removed: 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex101_20140930x10q.htm)] [added: 7, 2013)](http://www.sec.gov/Archives/edgar/data/1145197/000114519713000035/podd-ex101_2013930xq3.htm)] | | |

| [removed: 10.34*] [added: 10.37+] | | | [removed: [Form] [added: [Amendment No. 16, entered into effective as] of [removed: Incentive Stock Option Agreement under the Second Amended and Restated 2007 Stock Option] [added: August 15, 2018, to Supply Agreement, dated November 21, 2013, between Amgen Inc.] and [removed: Incentive Plan] [added: Insulet Corporation] (Incorporated by reference to Exhibit [removed: 10.7] [added: 10.1] to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, [removed: 2014,] [added: 2018,] filed November [removed: 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex107_20140930x10q.htm)] [added: 1, 2018)](http://www.sec.gov/Archives/edgar/data/1145197/000114519718000015/podd-exx101_20180930x10q.htm)] | | |

| [removed: 10.38*] [added: 10.25*] | | | [Form of Non-Qualified Stock Option Agreement [removed: for Michael Levitz, David Colleran and Michael] [added: for](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000071/podd-ex101_2015128xs8.htm) [Michael] Spears (Incorporated by reference to Exhibit 10.1 to our Registration Statement on Form S-8 (No. 333-208387) filed December 8, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000071/podd-ex101_2015128xs8.htm) | | |

| [removed: 10.39*] [added: 10.26*] | | | [Amended and Restated Executive Severance Plan, effective as of January 1, 2019 (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed October 22, 2018)](http://www.sec.gov/Archives/edgar/data/1145197/000115752318002092/a51886773ex10_1.htm) | | |

| [removed: 10.40*] [added: 10.30*] | | | [removed: [Insulet Corporation Employee Stock Purchase Plan (Amended] [added: [Offer Letter between Wayde D. McMillan] and [removed: Restated February 27, 2019)] [added: Insulet Corporation, dated January 3, 2019] (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed [removed: May 30, 2019)](http://www.sec.gov/Archives/edgar/data/1145197/000114519719000023/insuletcorporationemployee.htm)] [added: on January 7, 2019)](http://www.sec.gov/Archives/edgar/data/1145197/000115752319000039/a51922220ex10_1.htm)] | | |

| [removed: 10.41*] [added: 10.28*] | | | [Form of Employee Non-Competition and Non-Solicitation Agreement by and between Insulet Corporation and each of its executive officers (Incorporated by reference to Exhibit 10.17 to Amendment No. 2 to our Registration Statement on Form S-1 (File No. 333-140694), filed April 25, 2007)](http://www.sec.gov/Archives/edgar/data/1145197/000095013507002416/b63591a2exv10w17.txt) | | |

| [removed: 10.42*] [added: 10.29*] | | | [Offer Letter between Shacey Petrovic and Insulet Corporation, dated September 10, 2018 (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed September 14, 2018)](http://www.sec.gov/Archives/edgar/data/1145197/000115752318001929/a51865882ex10_1.htm) | | |

| [removed: 10.43*] [added: 10.39*] | | | [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 filed on January 7, 2019)](http://www.sec.gov/Archives/edgar/data/1145197/000115752319000039/a51922220ex10_1.htm)] [added: 10-Q](http://www.sec.gov/Archives/edgar/data/1145197/000114519719000020/podd-exx102_20190331x10q.htm)[,](http://www.sec.gov/Archives/edgar/data/1145197/000114519719000020/podd-exx102_20190331x10q.htm) [filed May 3, 2019).](http://www.sec.gov/Archives/edgar/data/1145197/000114519719000020/podd-exx102_20190331x10q.htm)] | | |

| [removed: 10.44*] [added: 10.35] | | | [removed: [Employment] [added: [Purchase and Sale] Agreement by and between [removed: Insulet Corporation] [added: 100 Nagog Park Limited Partnership] and [removed: Patrick J. Sullivan] [added: Insulet Corporation,] dated [removed: September] [added: December] 16, [removed: 2014] [added: 2016] (Incorporated by reference to Exhibit [removed: 10.2] [added: 1.1] to our Current Report on Form 8-K filed [removed: September 16, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000119312514343153/d790127dex102.htm)] [added: December 20, 2016 (Items 1.01 and 9.01)](http://www.sec.gov/Archives/edgar/data/1145197/000115752316007605/a51481585ex1_1.htm)] | | |

| [removed: 10.47+] [added: 10.32+] | | | [removed: [Materials] [added: [First Amendment to Materials] Supplier Agreement between Insulet Corporation and Flextronics Medical Sales and Marketing, Ltd, [removed: dated September] [added: entered into on June 29, 2018 and made effective as of January] 1, [removed: 2016] [added: 2018] (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, [removed: 2016,] [added: 2018,] filed [removed: November 4, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000100/podd-exx101_2016930x10q.htm)] [added: August 2, 2018)](http://www.sec.gov/Archives/edgar/data/1145197/000114519718000011/podd-exx101_20180630x10q.htm)] | | |

| [removed: 10.48+] [added: 10.41++] | | | [removed: [First] [added: [Second] Amendment to Materials Supplier Agreement between Insulet Corporation and Flextronics Medical Sales and Marketing, Ltd, entered into on [removed: June 29, 2018] [added: December 17, 2020] and made effective as of [removed: January] [added: October] 1, [removed: 2018 (Incorporated] [added: 2020](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1057_20201231x10k.htm) [(I](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1057_20201231x10k.htm)[n](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1057_20201231x10k.htm)[corporated] by reference to Exhibit [removed: 10.1] [added: 10.57] to our [removed: Quarterly] [added: Annual] Report on Form [removed: 10-Q for the fiscal quarter ended June 30, 2018, filed August 2, 2018)](http://www.sec.gov/Archives/edgar/data/1145197/000114519718000011/podd-exx101_20180630x10q.htm)] [added: 10-K](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1057_20201231x10k.htm) [filed February 24, 2021)](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1057_20201231x10k.htm)[.](https://www.sec.gov/Archives/edgar/data/1145197/000114519721000009/podd-ex1057_20201231x10k.htm)] | | |