Insulet (PODD) 10-K risk factor changes: FY2020 vs FY2019

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

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

Our main product is the Omnipod System, [added: from] which we [removed: introduced] [added: expect] to [removed: the market in 2005.][added: continue to derive nearly all our revenue.]

[removed: | • |] [added: -] 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 payors and people with insulin-dependent diabetes; [removed: |]

[removed: | • |] [added: -] manufacturing problems or capacity constraints; [removed: |]

[removed: | • |] [added: -] actual or perceived quality problems; [removed: |]

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

[removed: | • |] [added: -] claims that any portion of the Omnipod System infringes on [removed: patent rights or other] intellectual property rights [removed: owned by other parties; |][added: of others;]

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

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

[removed: | • |] [added: -] the inability of users to continue paying for our products; [removed: |]

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

[removed: | • |] [added: -] competitive [removed: pricing and related factors;] [added: pricing;] and [removed: |]

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

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

[removed: 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.

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 [removed: coverage under section 5000A of the Internal Revenue Code of 1986,] [added: coverage,] commonly referred to as the “individual [removed: mandate”, effective January 1, 2019.][added: mandate”.]

Further, the Bipartisan Budget Act of 2018 among other things, amended the Medicare [removed: statute, effective January 1, 2019,] [added: 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%.

It is possible that the ACA, as currently enacted or as it may be amended in the future, and other healthcare reform measures that may be adopted in the future, could have an adverse effect on our industry [removed: generally] and on our ability to maintain or increase sales of any of our products.

[removed: | • |] [added: -] revenue generated by sales of our current products and any other future products that we may develop; [removed: |]

[removed: | • |] [added: -] costs associated with capital expenditures, including adding [removed: further] [added: additional] manufacturing capacity; [removed: |]

[removed: | • |] [added: -] costs associated with [added: any expansion, including] expanding our sales and marketing efforts globally; [removed: |]

[removed: | • |] [added: -] expenses we incur in manufacturing and selling our products; [removed: |]

[removed: | • |] [added: -] costs of developing new products or technologies and enhancements to our products; [removed: |]

[removed: | • |] [added: -] costs associated with [removed: any expansion; |][added: litigation; and]

[removed: | • |] [added: -] costs of complying with regulatory requirements, including obtaining and maintaining FDA approval or clearance of our current or future products; [removed: |]

[removed: | • |] [added: -] the number and timing of any acquisitions or other strategic transactions. [removed: |]

We may in the future seek additional funds from public and private stock offerings, borrowings under credit lines or other [removed: sources.][added: sources, and we may need to raise additional debt or equity financing to repay our outstanding Senior Convertible Notes.]

Our ability to raise additional capital may be adversely impacted by current economic conditions, including [removed: the effects of] any [removed: disruptions] [added: sustained disruption] to the credit and financial [removed: markets.][added: markets from the COVID-19 pandemic.]

We may not be able to generate sufficient cash [added: flow from operations] to service our [removed: indebtedness represented by our Convertible Senior Notes.][added: debt, which is substantial.]

As of December 31, [removed: 2019,] [added: 2020,] we had [removed: outstanding principal amounts due] [added: debt] of [added: $1.3 billion, including] $1.2 billion [removed: on our] [added: aggregate principal amount of] Convertible Senior Notes, which mature between 2024 and 2026.

We cannot [removed: assure you] [added: guarantee] that we will maintain a level of cash flows from operating activities sufficient to permit us to [removed: pay] [added: repay] the [removed: principal, premium, if any, and interest on] [added: principal or service] our [removed: indebtedness.][added: interest.]

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

In addition, [removed: a subsidiary of Flex] [added: two third-party contract manufacturers] in China [removed: performs] [added: perform] assembly and [removed: supplies] [added: supply] a significant portion of all finished Omnipod Systems.

We do not have long-term supply agreements with all our suppliers, and, in many cases, we, or [removed: Flex on] our [removed: behalf,] [added: contract manufacturers,] make purchases based on individual purchase orders.

[removed: | • |] [added: -] we are not a major customer of many of our suppliers, and these suppliers may therefore give other customers’ needs higher priority than ours; [removed: |]

[removed: | • |] [added: -] we may not be able to obtain an adequate supply in a timely manner or on commercially reasonable terms; [removed: |]

[removed: | • |] [added: -] our suppliers may make errors in manufacturing that could negatively affect the safety or efficacy of our products, cause delays in shipment or negatively affect our reputation; [removed: |]

[removed: | • |] [added: -] we may have difficulty locating and qualifying alternative suppliers for our sole-source supplies; [removed: |]

[removed: | • |] [added: -] switching components may require product redesign and submission to the FDA of a new 510(k); [removed: |]

We cannot accurately predict the complete

Risks Related to Product Development, Market Access and Competition

We face competition from numerous competitors, many of whom have far greater resources than we have, and, as a result, we may not be able to compete effectively.

These companies may have competitive advantages over us, including:

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

The Omnipod System is based on our proprietary technology, but a number of companies, medical researchers and pharmaceutical companies are pursuing

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

We may be unable to adequately protect our intellectual property rights.

Our success depends in part on our ability to maintain the proprietary nature of our technologies.

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

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 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 may be limited in certain circumstances outside the United States.

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

If we are unable to sufficiently protect our intellectual property rights and our intellectual property is disclosed or misappropriated, our competitiveness could be impaired, which would limit our growth and future revenue.

To protect our intellectual property, we may need to assert claims of infringement against third parties.

The outcome of litigation to enforce our intellectual property rights is highly unpredictable.

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

Risks Related to Economic Conditions and Operating Internationally

Our financial condition and results of operations have been and may to continue to be adversely affected by the COVID-19 pandemic.

The COVID-19 pandemic has created significant volatility, uncertainty and economic disruption in the markets we sell our products into and operate in and negatively impacted business and healthcare activity globally.

The pandemic and preventative measures taken to contain or mitigate the outbreak, have caused, and are continuing to cause, business slowdown or shutdown in affected areas and disruption in the financial markets globally.

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

The COVID-19 pandemic also has the potential to significantly impact our supply chain if the manufacturing plants that produce our products or product components, the distribution centers where we manage our inventory, or the operations of our logistics and other service providers, including third parties that sterilize our products, are disrupted, temporarily closed or experience worker shortages for a sustained period of time.

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

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.

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

The further spread of COVID-19, and the requirements to take action to help limit the spread of the illness, may impact our ability to carry out our business as usual.

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, including for our Omnipod 5.

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

The effects of Brexit will depend on the terms of the U.K.’s future relationship with the European Union.

Although it is unknown what those terms will be, it is possible that there could be greater restrictions on imports and exports and on the movement of people between the U.K. and European Union countries, and increased regulatory complexities.

Because we do business in the U.K., the U.K. Bribery Act also extends to our interaction with public and private sector entities and persons outside the U.K., including in the U.S. Our policies mandate compliance with these anti-bribery laws.

We operate

Risks Related to Supply Chain, Operations and Third-Party Arrangements

Further, following the COVID-19 pandemic there may be increased pressure for U.S. medical device companies to reduce dependency on China for their supply chain.

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

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

In addition, we have a commercial agreement with Dexcom that allows us to launch Omnipod 5 with integration to Dexcom’s CGM and have a development agreement with Abbott to integrate Abbott’s CGM into Omnipod 5.

We also have a partnership with Glooko that allows the Omnipod System to connect with Glooko’s cloud-based diabetes data management system so that users and healthcare providers can monitor user data, including insulin delivery trends and blood glucose levels.

Although we achieved profitability in 2018, we previously incurred significant losses since inception and cannot assure you that we will sustain profitability.

Prior to 2018 and since our inception in 2000, we incurred significant losses.

Our losses from continuing operations for the years ended December 31, 2017, 2016 and 2015 were $26.8 million, $27.2 million and $61.6 million, respectively.

The extent of any future losses and the timing of profitability are uncertain, and we may not sustain profitability.

As of December 31, 2019, we had an accumulated deficit of $672.0 million.

We may experience significant fluctuations in our quarterly results of operations.

The fluctuations in our quarterly results of operations have resulted, and may continue to result, from numerous factors, including:

| | |

| --- | --- |

| • | delays in shipping due to capacity constraints; |

| • | practices of health insurance companies and other third-party payors with respect to reimbursement for our current or future products; |

| • | market acceptance of our products; |

| • | our ability to manufacture our products efficiently, or at all; |

| • | transitions in our distribution channel; |

| • | timing of regulatory approvals and clearances; |

| • | new product introductions; |

| • | competition; and |

| • | timing of research and development expenditures. |

These factors, some of which are not within our control, may cause the price of our stock to fluctuate substantially.

If our quarterly results of operations fail to meet or exceed the expectations of securities analysts or investors, our stock price could drop suddenly and significantly.

We believe the quarterly comparisons of our financial results should not be the only indication of our future performance.

The failure of the Omnipod System to achieve and maintain significant market acceptance or any factors that negatively impact sales of this product will adversely affect our business, financial condition and results of operations.

We expect to continue to derive nearly all our revenue from the sale of this product.

| • | conversion rate of referrals to actual sales of the Omnipod System; |

Our ability to sustain profitability may depend on our ability to sustain or further reduce the per unit cost of producing the Omnipod System by increasing customer orders, increasing manufacturing volume and productivity and reducing raw material and overhead costs per unit.

To sustain profitability, we may need to, among other things, sustain or further reduce the per unit cost of the Omnipod System.

If we are unable to sustain or further reduce raw material and manufacturing overhead costs through volume purchase discounts, negotiation of improved pricing and increased productivity and production capacity, our ability to sustain profitability could be negatively affected.

The occurrence of one or more factors that negatively impact the manufacturing or sales of the Omnipod System or increase our raw material costs could prevent us from sustaining our desired increase in manufacturing volume, which would prevent us from sustaining and further increasing profitability.

Adverse changes in general economic conditions in the United States and outside of the United States, predominantly in Europe, could adversely affect us.

We are subject to the risks arising from adverse changes in general economic market conditions.

A U.S. or global recession, could negatively impact our current and prospective customers, adversely affect the financial ability of health insurers to pay claims, adversely impact our ability to pay our expenses and ability to obtain financing of our operations, cause delays or other problems with key suppliers and increase the risk of counterparty failures.

Healthcare spending in the United States, Canada and Europe could be negatively affected in the event of a downturn in economic conditions.

For example, U.S. consumers who have lost their jobs or healthcare coverage may no longer be covered by an employer-

sponsored health insurance plan and consumers reducing their overall spending may eliminate purchases requiring co-payments.

Since the sale of the Omnipod System to a new user is generally dependent on the availability of third-party reimbursement and may require the user to make a significant co-payment, an economic downturn could reduce the referrals generated by our sales force and thereby reduce our sales orders.

Similarly, existing users could cease purchasing the Omnipod System and return to MDI or other less-costly therapies, which would cause our consumer attrition rate to increase.

Any decline in new orders or increase in our consumer attrition rate would reduce our revenue, which in turn would make it more difficult to achieve our per-unit cost-savings goals, which we are attempting to attain in part through increases in our manufacturing volume.

There are provisions of law that provide for the creation of a new public-private Patient-Centered Outcomes Research Institute tasked with identifying comparative effectiveness research priorities, including establishing a research project agenda and contracting with entities to conduct the research.

Research findings published by this institute are publicly disseminated.

It is difficult at this time to determine whether a comparative effectiveness analysis impacting our business will be done, and assuming one is, what impact that analysis will have on the Omnipod System or our future financial results.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our [removed: selected financial data and our] consolidated financial statements and the accompanying notes included in this annual report.

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

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 [removed: time] [added: time;] and its wireless companion, the handheld PDM.

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

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

To assist in achieving this mission, we are focused on the following [added: key] strategic [removed: objectives:][added: imperatives:]

[removed: | • |] [added: -] delivering consumer-focused innovation; [removed: |]

[removed: | • |] [added: -] expanding our global [removed: footprint;] [added: addressable market;] and [removed: |]

[removed: | • |] [added: -] driving operational excellence. [removed: |]

To achieve this goal, [removed: we expect] our efforts [removed: in 2020 to focus primarily] [added: are focused] on the launch of Omnipod [removed: Horizon in the United States.][added: 5, powered by Horizon™ (“Omnipod 5”), our AID system.]

[removed: In] [added: Additionally, in] order to support our continued growth and the expected launch of Omnipod [removed: Horizon,] [added: 5] in [removed: 2020 we also plan to focus on] the [removed: startup] [added: first half] of [removed: our second] [added: 2021, we recently installed a third highly automated] manufacturing line in [removed: our Acton facility and] the [removed: installation of a third] U.S. [removed: manufacturing line, which we expect to begin production] on [added: which salable product is expected] in 2021.

[removed: expect to enter] [added: In 2020, we entered] five new countries in Western Europe and the Middle East [removed: and further roll out DASH in Europe and Canada] to expand the commercial sale of Omnipod and our global footprint.

Achieving [removed: these objectives] [added: the above strategic imperatives] is expected to require additional investments in certain initiatives and personnel, as well as enhancements to our supply chain operation capacity, efficiency and effectiveness.

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

[removed: | Revenue | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |][added: *Cost of Revenue*]

[removed: | Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |][added: Operating Expenses]

| Loss on extinguishment of debt | [removed: (8.7] | | [removed: ) | |] — | | | | [removed: (8.7] | | [removed: ) | | NM | | | — | | | | (0.6 | | ) | | 0.6 | | |] [added: 8.7] | [removed: NM] | |

| Income tax expense | [removed: (2.9] | | [removed: ) | | (1.9 | | ) | | (1.0 | | ) | | 53 | % | | (1.9 | | ) | | (0.2 |] [added: 2.9] | [removed: )] | | [removed: (1.7] | | [removed: )] | [added: 2.9] | [removed: 850] | [removed: %] |

Comparison of the Years Ended December [removed: 31, 2019 and] [added: 31, 2020 and] December [removed: 31, 2018][added: 31, 2019]

Drug Delivery revenue [removed: decreased $3.6] [added: for 2020 increased $4.8] million, or [removed: 5%,] [added: 7.4%,] to [removed: $64.7] [added: $69.5] million, compared with [removed: 2018.][added: $64.7 million in 2019.]

[removed: For 2020,] [added: In 2021,] we expect strong Omnipod revenue growth driven by continued market penetration and [removed: continued] volume growth of Omnipod DASH, primarily in the [removed: U.S.] pharmacy [removed: channel, partially offset by lower Drug Delivery revenue, due to a lower demand forecast.][added: channel.]

Gross margin was [removed: 65.1% of revenue] [added: 64.4%] in [removed: 2019,] [added: 2020,] compared with [removed: 65.7%] [added: 65.1%] in [removed: 2018.][added: 2019.]

[removed: Research] [added: *Research] and [removed: Development][added: Development*]

Research and development expenses for [removed: 2019] [added: 2020] increased [removed: $39.2] [added: $14.5] million, or [removed: 43%,] [added: 11.0%,] to [removed: $129.7] [added: $146.8] million, compared with [removed: $90.5] [added: $132.3] million in [removed: 2018.][added: 2019.]

We expect research and development spending [removed: for the full year 2020] [added: in 2021] to increase compared with [removed: 2019.][added: 2020 as we continue to invest in advancing our innovation and clinical pipeline.]

[removed: General] [added: *Selling, General] and [removed: Administrative][added: Administrative*]

[removed: General] [added: Selling, general] and administrative expenses for [removed: 2019] [added: 2020] increased [removed: $9.4] [added: $86.0] million, or [removed: 9%,] [added: 28.9%,] to [removed: $115.5] [added: $384.0] million, compared with [removed: $106.1] [added: $298.0] million in [removed: 2018.][added: 2019.]

[removed: Interest] [added: *Interest] Expense, [removed: Net of Portion Capitalized][added: Net*]

Interest expense, net for [removed: 2019] [added: 2020] increased [removed: $5.7] [added: $17.4] million, or [removed: 20%,] [added: 62.8%,] to [removed: $34.6] [added: $45.1] million, compared with [removed: 2018.][added: $27.7 million in 2019.]

[removed: The] [added: This] increase [removed: in interest expense, net] [added: was] primarily [removed: resulted from] [added: due to] a [removed: $6.3] [added: $9.6] million increase in non-cash interest expense resulting from [added: 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 [removed: notes.][added: 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.]

[removed: Loss] [added: *Loss] on Extinguishment of [removed: Debt][added: Debt*]

[removed: Interest and Other] [added: *Other] Income, [removed: Net][added: Net*]

Other income, net for [removed: 2019] [added: 2020] increased [removed: $1.1] [added: $2.4] million, to [removed: $7.8] [added: $3.3] million, compared with [removed: $6.7] [added: $0.9] million in [removed: 2018.][added: 2019.]

[removed: Income] [added: *Income] Tax [removed: Expense][added: Expense*]

Income tax expense was $2.9 million [removed: and $1.9 million] on pre-tax income of [removed: $14.5] [added: $9.7] million and [removed: $5.2] [added: $14.5] million for [removed: 2019] [added: both 2020] and [removed: 2018,] [added: 2019,] respectively.

Our effective tax rate was [removed: 19.8%] [added: 29.6%] and [removed: 37.0%] [added: 19.8%] for [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] respectively.

The [removed: decrease] [added: increase] in our effective tax rate primarily resulted from [removed: an increase in earnings] [added: a decrease to pre-tax income] in the U.S., which has a [removed: full] valuation allowance.

[removed: See] [added: Refer to] Note [removed: 18] [added: 12] to [removed: the] [added: our] consolidated financial statements for additional information [removed: on our income tax expense.][added: regarding these transactions.]

[removed: Interest Expense, Net of Portion Capitalized][added: | Interest expense, net | | | 45.1 | | | | | | 27.7 | | |]

As of December 31, [removed: 2019,] [added: 2020,] we had [removed: $213.7] [added: $907.2] million in cash and cash equivalents and [removed: $220.8] [added: $40.4] million of investments in marketable securities.

- driving access and awareness;

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.

Based on the results of the feasibility work, we plan to conduct additional studies with the goal to further expand Omnipod 5’s indications.

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.

In 2020, we completed the roll out of Omnipod DASH, our digital mobile Omnipod platform, in the countries we serve in Europe.

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.

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 countries over the long term.

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.

We are continuing to expand internationally in a targeted and strategic manner.

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.

| (In millions) | | | 2020 | | | | | | 2019 | | | | | | % Change | | | | | | Currency Impact | | | | | | Constant Currency(1) | | |

| U.S. Omnipod | | | $ | 526.9 | | | | | $ | 420.4 | | | | | 25.3 | | % | | | | — | | % | | | | 25.3 | | % |

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

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

| Drug Delivery | | | 69.5 | | | | | | 64.7 | | | | | | 7.4 | | % | | | | — | | % | | | | 7.4 | | % |

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

(1) Constant currency revenue growth is a non-GAAP financial measure which should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP.

See “Management’s Use of Non-GAAP Measures.”

Total revenue for 2020 increased $166.2 million, or 22.5%, to $904.4 million, compared with $738.2 million in 2019.

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

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.

*U.S. Omnipod*

U.S. Omnipod revenue for 2020 increased $106.5 million, or 25.3%, to $526.9 million, compared with $420.4 million in 2019.

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 due in part to the fact that we offer the PDM for no charge.

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

*International Omnipod*

International Omnipod revenue for 2020 increased $54.9 million, or 21.7%, to $308.0 million, compared with $253.1 million in 2019.

Excluding the 1.8% favorable impact of currency exchange, the remaining 19.9% increase was primarily due to higher volumes as we continue to expand awareness and access to the Omnipod.

Similar to in the U.S., in 2021, we expect higher International Omnipod revenue due to continued volume growth and market penetration aided by the full launch of Omnipod DASH throughout our international markets and our virtual training capabilities.

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.

*Drug Delivery*

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.

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

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

There are two primary types of insulin therapy practiced today: MDI therapy using syringes or insulin pens; and pump therapy using insulin pumps.

Insulin pumps are used to perform continuous subcutaneous insulin infusion, or insulin pump therapy, and typically use a programmable device and an infusion set to administer insulin into a person’s body.

Insulin pump therapy has been shown to provide people with insulin-dependent diabetes with numerous advantages relative to MDI therapy.

The Omnipod is currently available in the United States, Canada and certain countries in Europe and the Middle East.

We sell the Omnipod through direct sales to consumers or through our distribution partners and most recently in the U.S. through the pharmacy channel.

| | |

| --- | --- |

| • | ensuring the best customer experience globally; |

In the first half of 2019, we began production at our new highly automated manufacturing facility in Acton, Massachusetts, which also serves as our new global headquarters.

We expect that, following start up related activities, the new facility will allow us to lower our manufacturing costs, increase supply redundancy, add capacity closer to our largest customer base and support growth.

As of December 31, 2019, we had made cumulative investments of approximately $320 million in property, plant and infrastructure related to the new facility.

We expect to continue to expand our investment in this facility in 2020 to support the growth of our business.

Additionally, in the first half of 2019, we completed a full market launch of Omnipod DASH in the United States.

Omnipod DASH is our next-generation digital mobile Omnipod platform, featuring a secure Bluetooth enabled Pod and PDM with a color touch screen user interface supported by smartphone connectivity.

In December of 2019, we introduced DASH to select European markets.

In late 2019, we completed our pre-pivotal trial for Omnipod Horizon, a closed loop control system that utilizes the DASH mobile platform to allow the Pod to communicate with a continuous glucose monitor and help control insulin delivery utilizing an algorithm located on the Pod.

In December 2019, we began patient enrollment in our pivotal trial.

We expect to launch Omnipod Horizon in the second half of 2020.

While we expect Horizon to contribute to our long-term revenue growth, we do not expect it to meaningfully contribute to growth in 2020.

Additionally, in 2020, we

While we expect these new countries to contribute to our long-term revenue growth, we do not expect them to have a meaningful contribution in 2020.

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

| (In millions) | 2019 | | | | 2018 | | | | Change $ | | | | Change % | | | 2018 | | | | 2017 | | | | Change $ | | | | Change % | |

| U.S. Omnipod | $ | 420.4 | | | $ | 323.5 | | | $ | 96.9 | | | 30 | % | | $ | 323.5 | | | $ | 271.6 | | | $ | 51.9 | | | 19 | % |

| International Omnipod | 253.1 | | | | 172.0 | | | | 81.1 | | | | 47 | % | | 172.0 | | | | 120.0 | | | | 52.0 | | | | 43 | % |

| Total Omnipod | 673.5 | | | | 495.5 | | | | 178.0 | | | | 36 | % | | 495.5 | | | | 391.6 | | | | 103.9 | | | | 27 | % |

| Drug Delivery | 64.7 | | | | 68.3 | | | | (3.6 | | ) | | (5 | )% | | 68.3 | | | | 72.2 | | | | (3.9 | | ) | | (5 | )% |

| Total revenue | 738.2 | | | | 563.8 | | | | 174.4 | | | | 31 | % | | 563.8 | | | | 463.8 | | | | 100.0 | | | | 22 | % |

| Cost of revenue | 257.9 | | | | 193.6 | | | | 64.3 | | | | 33 | % | | 193.6 | | | | 186.6 | | | | 7.0 | | | | 4 | % |

| Gross profit | 480.3 | | | | 370.2 | | | | 110.1 | | | | 30 | % | | 370.2 | | | | 277.2 | | | | 93.0 | | | | 34 | % |

| Gross margin | 65.1 | | % | | 65.7 | | % | | | | | | | | | 65.7 | | % | | 59.8 | | % | | | | | | | |

| Research and development | 129.7 | | | | 90.5 | | | | 39.2 | | | | 43 | % | | 90.5 | | | | 75.7 | | | | 14.8 | | | | 20 | % |

| Sales and marketing | 185.1 | | | | 146.2 | | | | 38.9 | | | | 27 | % | | 146.2 | | | | 124.2 | | | | 22.0 | | | | 18 | % |

| General and administrative | 115.5 | | | | 106.1 | | | | 9.4 | | | | 9 | % | | 106.1 | | | | 84.7 | | | | 21.4 | | | | 25 | % |

| Total operating expenses | 430.3 | | | | 342.8 | | | | 87.5 | | | | 26 | % | | 342.8 | | | | 284.6 | | | | 58.2 | | | | 20 | % |

| Operating income (loss) | 50.0 | | | | 27.4 | | | | 22.6 | | | | 82 | % | | 27.4 | | | | (7.4 | | ) | | 34.8 | | | | 470 | % |

| Interest expense, net of portion capitalized | (34.6 | | ) | | (28.9 | | ) | | (5.7 | | ) | | 20 | % | | (28.9 | | ) | | (21.2 | | ) | | (7.7 | | ) | | 36 | % |

| Interest and other income, net | 7.8 | | | | 6.7 | | | | 1.1 | | | | 16 | % | | 6.7 | | | | 2.6 | | | | 4.1 | | | | 158 | % |

| Income (loss) before income taxes | 14.5 | | | | 5.2 | | | | 9.3 | | | | 179 | % | | 5.2 | | | | (26.6 | | ) | | 31.8 | | | | 120 | % |

| Net income (loss) | $ | 11.6 | | | $ | 3.3 | | | $ | 8.3 | | | 252 | % | | $ | 3.3 | | | $ | (26.8 | ) | | $ | 30.1 | | | 112 | % |

As of December 31, [removed: 2019,] [added: 2020,] we had outstanding debt related to our convertible senior notes recorded on our consolidated balance sheet of [removed: $887.9] [added: $933.1] million, net of unamortized discount and issuance costs totaling [removed: $314.6] [added: $269.4] million.

The fair value of the debt, which was [removed: $1.35] [added: $2.0] billion as of December 31, [removed: 2019,] [added: 2020,] is also impacted by changes in our stock price.

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

Approximately 34% of our revenue was denominated in foreign currencies for the year ended December 31, [removed: 2019.][added: 2020.]

Net realized and unrealized gains (losses) from foreign currency transactions are included in [removed: interest and] other [removed: income,] [added: income (expense),] net in the consolidated statement of [removed: operations] [added: income] and amounted to [removed: $0.6] [added: a loss of $3.2] million for the year ended December 31, [removed: 2019.][added: 2020.]

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

The Omnipod System [removed: consists of the following:] [added: includes:] the Omnipod Insulin Management System (“Omnipod”) and the Omnipod DASHTM Insulin Management System (“Omnipod DASH” or “DASH”), our [removed: next generation] digital mobile Omnipod platform.

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

[removed: The Pod] [added: It] can be worn in multiple locations, including the abdomen, hip, back of upper arm, upper thigh or lower [removed: back and, because it is waterproof, there is no need to remove it when showering, swimming or performing other activities.][added: back.]

We believe [removed: that] the Omnipod System’s [removed: unique] [added: innovative] proprietary design and [added: differentiated] features allow people with insulin-dependent diabetes to [added: live their lives and] manage their [removed: diabetes] [added: diabetes,] with unprecedented freedom, comfort, convenience and ease.

Omnipod DASH, launched in [removed: 2019,] [added: 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.

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

We believe that these [removed: distinct] advantages, [removed: including] [added: along with] technological advancements and increased awareness of insulin pump therapy [removed: as compared to other available insulin therapies] will continue to generate demand for insulin pump devices.

The Omnipod System is [removed: an innovative] [added: a] continuous insulin delivery system that provides all the benefits of insulin pump therapy in a [removed: way no conventional insulin pump can.][added: unique way.]

| Pod | [added: | |] Omnipod PDM | [added: | |] Omnipod DASH PDM | [added: | |]

The Omnipod System [removed: is a] [added: features two] discreet [removed: two-part design, the Pod] and [removed: the PDM,] [added: easy-to-use devices] that eliminates the need for the external tubing required with conventional [removed: pumps.][added: pumps:]

[removed: | • |] The Pod [removed: is a small, lightweight, self-adhesive device that the user fills with insulin and wears directly on the body. The Pod] delivers precise, personalized doses of insulin into the body through a small flexible tube (called a [removed: cannula), based on instructions that the user programs into the Pod’s wireless companion, the PDM. |][added: cannula); and]

[removed: | • | The PDM is] [added: - the Personal Diabetes Manager (“PDM”),] a wireless, handheld device that programs the Pod with the user’s personalized insulin-delivery instructions and, wirelessly monitors the Pod’s operation. [removed: |]

The Omnipod System provides continuous insulin delivery at preset rates, eliminating the need for individual insulin [removed: injections and the interruptions that come with them.][added: injections.]

The Omnipod System works [removed: much] like the pancreas of a person without diabetes by delivering insulin in two ways:

[removed: | • |] [added: -] A small, constant background supply of insulin is delivered automatically at a programmed rate, all day and night. [removed: |]

[removed: | • |] [added: -] An extra dose of insulin can be delivered when needed to match the carbohydrates in a [removed: meal or snacks] [added: snack] or [added: meal] to correct high blood glucose. [removed: |]

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

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

Several publications over the past decade have found that compared to [removed: multiple daily injections] [added: MDI] therapy, the use of the Omnipod System by individuals with both Type 1 and Type 2 diabetes across all age groups is associated with good glycemic control and reduced frequency and severity of hypoglycemic episodes.

These results are consistent with [removed: other] published literature of other continuous subcutaneous insulin infusion [removed: devices like the Omnipod System.][added: devices.]

[removed: Consumers] [added: In the United States, consumers] generally have commercial insurance, Medicare or Medicaid coverage that pays for the product.

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

For the year ended December 31, [removed: 2019,] [added: 2020,] approximately [removed: 65%] [added: 70%] of our Omnipod System sales were through intermediaries.

Revenue for customers comprising [removed: more than] 10% [added: or more] of total revenue was as follows:

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

| | | [added: | | | | 2020 | | | | | |] 2019 | | [added: | | | |] 2018 | | [removed: 2017] |

| Amgen, Inc. | | [added: | | | | * | | | | | |] * | | [added: | | | |] 12% | | [removed: 15%] |

| Cardinal Health Inc. and affiliates | | [added: | | | | 10% | | | | | |] 11% | | [added: | | | |] 12% | | [removed: 11%] |

[removed: | • |] [added: -] Build consumer awareness about the features and benefits that the Omnipod System provides. [removed: |]

[removed: | • |] [added: -] Build physician support by increasing the clinical evidence that demonstrates the benefits that the Omnipod System provides and improving the monitoring data available to physicians providing diabetes care. [removed: |]

[removed: | • |] [added: -] Provide payors with the clinical and economic justification for why the Omnipod System provides a unique value to the people whom they insure. [removed: |]

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

Our non-insulin drug delivery product line [removed: also] competes with drug delivery device companies such as West Pharmaceutical Services, Inc.

Our research and development efforts are primarily focused on making improvements to the Omnipod System, including adding features and functionality that will deliver economic value, convenience and simplicity to [removed: users, and improving our supply chain operations.][added: users.]

Omnipod [added: 5, powered by] HorizonTM Automated Insulin Delivery System (“Omnipod [removed: Horizon”)][added: 5”)]

We are developing an automated insulin delivery [added: (“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 [added: (“CGM”)] to predict glucose levels into the future and automatically adjust the insulin dose required [removed: to help reduce the occurrence of blood glucose highs and lows.]

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

Omnipod [removed: Horizon] [added: 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 [removed: Continuous Glucose Monitoring] [added: CGM] technology and [removed: Automated Insulin Delivery] [added: 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.

- Type 1 diabetes is characterized by the body’s nearly complete inability to produce insulin.

It is frequently diagnosed during childhood or adolescence.

Individuals with Type 1 diabetes require daily insulin therapy to survive.

We estimate that four to four and a half million people have Type 1 diabetes in the countries we currently serve.

- Type 2 diabetes, the more common form, is characterized by the body’s inability to either properly utilize insulin or produce enough insulin.

Historically, Type 2 diabetes has occurred in later adulthood, but its incidence is increasing among the younger population, due primarily to increasing obesity.

Initially, many people with Type 2 diabetes attempt to manage their diabetes with improvements in diet, exercise and/or oral medications.

As their diabetes advances, some individuals progress to multiple drug therapies, which often include insulin therapy.

We estimate that approximately seven to seven and a half million people have Type 2 diabetes in the countries we currently serve.

There are two

| | | | | | | | | |

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

|  | | |  | | |  | | |

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

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.

It can be worn for up to three days at a time and, because it is waterproof, there is no need to remove it when showering, swimming or performing other activities.

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

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

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

With the launch of Omnipod DASH, we created an online training program for Omnipod DASH customers transitioning from Omnipod.

In addition, due to the challenges COVID-19 has presented, we have also been using virtual training to onboard new Omnipod customers transitioning from MDI.

Our virtual capabilities have allowed us to continue to onboard new customers despite COVID-19 and in a cost-effective manner.

Our distributors and intermediaries have also implemented virtual training programs.

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.

In addition, we have signed a development agreement to integrate Abbott Diabetes Care, Inc.’s CGM in the future and are also working on developing compatibility with iOS.

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

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.

Based on the results of the feasibility work, we plan to conduct additional studies with the goal of expanding Omnipod 5’s indications.

In addition to our focus on Omnipod 5, we are also working on innovation programs designed to drive:

- simplicity of user interaction with our systems;

- improved outcomes through algorithm advancements;

- insights and value from our growing datasets and analytics; and

- user choice of sensor and smartphone integrations.

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 addition to increasing supply redundancy and adding capacity closer to our North American customer base to support the growth of our business, we expect that once the Acton facility is fully utilized, the highly automated assembly process will be able to produce a globally cost competitive product.

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.

Insulin pump therapy has been shown to provide people with insulin-dependent diabetes with numerous advantages relative to MDI therapy.

The Omnipod System features two discreet and easy-to-use devices: a small, lightweight, self-adhesive disposable tubeless Omnipod device (“Pod”) that is worn on the body for up to three days at a time, and its wireless companion, the handheld Personal Diabetes Manager (“PDM”).

| | |

| --- | --- |

| • | Type 1 diabetes is characterized by the body’s nearly complete inability to produce insulin. It is frequently diagnosed during childhood or adolescence. Individuals with Type 1 diabetes require daily insulin therapy to survive. We estimate that three to four million people have Type 1 diabetes in the countries we currently serve. |

| • | Type 2 diabetes, the more common form, is characterized by the body’s inability to either properly utilize insulin or produce enough insulin. Historically, Type 2 diabetes has occurred in later adulthood, but its incidence is increasing among the younger population, due primarily to increasing obesity. Initially, many people with Type 2 diabetes attempt to manage their diabetes with improvements in diet, exercise and/or oral medications. As their diabetes advances, some individuals progress to multiple drug therapies, which often include insulin therapy. We estimate that approximately five to six million people have Type 2 diabetes in the countries we currently serve. |

The Omnipod System’s innovative design and differentiated features allow people with insulin-dependent diabetes to live their lives and manage their diabetes, with unprecedented freedom, comfort, convenience and ease.

| | | |

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

|  |  |  |

Our pricing model, which includes little or no initial investment, reduces the risk to third-party payors of significant up-front investments commonly associated with traditional tubed insulin pumps.

In Europe, in connection with of our assumption of direct operations in 2018, we have worked with local healthcare systems to transition coverage and payment processes for the Omnipod System as required.

| | | | | | | |

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

| Ypsomed Distribution AG and affiliates | | * | | * | | 22% |

These efforts include:

We plan to launch Omnipod Horizon with a continuous glucose monitor manufactured by Dexcom, Inc.; however, we have signed a development agreement to integrate Abbott Diabetes Care, Inc.’s continuous glucose monitor in the future.

“phone control”).

In July 2018, we announced positive results from a clinical trial finding that Omnipod Horizon performed well and was safe for over five days of use in adults, adolescents and children with Type 1 diabetes and in December 2019, we began patient enrollment in our pivotal trial.

We expect that, following start up related activities, the new facility will allow us to lower our manufacturing costs, increase supply redundancy, add capacity closer to our North American customer base and support growth.

To date, we have invested approximately $320 million in property, equipment and infrastructure related to the new facility.

We expect to continue to expand our investment in this facility in 2020 to support the growth of our business.

facilitate compliance with our specifications.

Our trademarks include OMNIPOD®, DASHTM, Omnipod CONTROLTM, Omnipod DISPLAYTM, Omnipod VIEWTM, OMNIPOD U-200TM, OMNIPOD U-500TM, HORIZONTM, Pod PalsTM and PodderTM.

If the FDA disagrees with a manufacturer’s determination regarding whether a new pre-market

These include, but are not limited to:

We have obtained the right to affix the CE Mark to the Omnipod and Omnipod DASH Systems.

We have been distributing the Omnipod in certain countries in Europe through intermediaries or directly to end-users since 2010 and have been distributing Omnipod throughout Canada since receiving Health Canada approval in 2009.

new safe harbor for certain fees manufacturers pay to PBMs for services to the manufacturers.

As of December 31, 2019, we had 1,350 full-time employees.

The information required by this Item is provided under “Legal Proceedings” in Note 13 to the consolidated financial statements included [removed: under] [added: in] Item 8 of this Form 10-K and is incorporated herein by reference.

[removed: Form 10-K][added: Form 10-K]

| ☒ | [added: | |] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | [added: | | | | |]

| | [added: | |] For the fiscal year [removed: ended December] [added: ended | | | December] 31, [removed: 2019] [added: 2020] | [added: | |]

| ☐ | [added: | |] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | [added: | |]

| | [added: | |] For the transition period from to | [added: | |]

Commission File [removed: Number 001-33462][added: Number 001-33462]

| | [added: | |] Delaware | | | | [added: | | | | | | | |] 04-3523891 | [added: | |]

| | [added: | |] (State or Other Jurisdiction of Incorporation or Organization) | | | | [added: | | | | | | | |] (I.R.S. Employer Identification No.) | [added: | |]

| | [added: | |] 100 Nagog Park | [added: | |] Acton | [added: | |] Massachusetts | | [added: | | | |] 01720 | [added: | |]

| | [added: | |] (Address of Principal Executive Offices) | | | | [added: | | | | | | | |] (Zip Code) | [added: | |]

Registrant’s telephone number, including area code: [removed: (978) 600-7000][added: (978) 600-7000]

| Title of Each Class | [added: | |] Trading Symbol(s) | [added: | |] Name of Each Exchange on Which Registered | [added: | |]

| Common Stock, $0.001 Par Value Per Share | [added: | |] PODD | [added: | |] The NASDAQ Stock Market, LLC | [added: | |]

| Large accelerated filer | [added: | |] x | | [added: | | | |] Non-accelerated filer | [added: | |] ¨ | [added: | |]

| Accelerated filer | [added: | |] ¨ | | [added: | | | |] Smaller reporting company | [added: | |] ☐ | [added: | |]

| | | | [added: | | | | | |] Emerging growth company | [added: | |] ☐ | [added: | |]

Yes ☐ No [removed: x][added: ☒]

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: 2019] [added: 2020] was approximately [removed: $7.2] [added: $12.7] billion.

The number of shares of common stock outstanding as of February [removed: 20, 2020] [added: 18, 2021] was [removed: 62,863,402.][added: 66,080,324.]

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: 2019.][added: 2020.]

| Item 1 | [removed: [Business](#s3AD2D49FB68256B3A28AEEC7A75433BF)] | [removed: [3](#s3AD2D49FB68256B3A28AEEC7A75433BF)] | [added: [Business](#id101d1fa5bd94d659e900a3dbd836cf4_13) | | | [3](#id101d1fa5bd94d659e900a3dbd836cf4_13) | | |]

| Item 1A | [added: | |] [Risk [removed: Factors](#sD48E6697508E5347A0E475BCE37848A9)] [added: Factors](#id101d1fa5bd94d659e900a3dbd836cf4_16)] | [removed: [13](#sD48E6697508E5347A0E475BCE37848A9)] | [added: | [16](#id101d1fa5bd94d659e900a3dbd836cf4_16) | | |]

| Item 1B | [added: | |] [Unresolved Staff [removed: Comments](#s41A108E864885F3EBB0B7C54DCCCC4C7)] [added: Comments](#id101d1fa5bd94d659e900a3dbd836cf4_19)] | [removed: [31](#s41A108E864885F3EBB0B7C54DCCCC4C7)] | [added: | [30](#id101d1fa5bd94d659e900a3dbd836cf4_19) | | |]

| Item 2 | [removed: [Properties](#sCCDD9CF9C5CA513A819C375284E971FA)] | [removed: [31](#sCCDD9CF9C5CA513A819C375284E971FA)] | [added: [Properties](#id101d1fa5bd94d659e900a3dbd836cf4_22) | | | [30](#id101d1fa5bd94d659e900a3dbd836cf4_22) | | |]

| Item 3 | [added: | |] [Legal [removed: Proceedings](#s1DB5BDF2398057579FDED8DAA678810C)] [added: Proceedings](#id101d1fa5bd94d659e900a3dbd836cf4_25)] | [removed: [31](#s1DB5BDF2398057579FDED8DAA678810C)] | [added: | [30](#id101d1fa5bd94d659e900a3dbd836cf4_25) | | |]

| Item 4 | [added: | |] [Mine Safety [removed: Disclosures](#s641B5EC3D97A5205925461A8C28D0807)] [added: Disclosures](#id101d1fa5bd94d659e900a3dbd836cf4_28)] | [removed: [31](#s641B5EC3D97A5205925461A8C28D0807)] | [added: | [30](#id101d1fa5bd94d659e900a3dbd836cf4_28) | | |]

| Item 5 | [added: | |] [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity [removed: Securities](#sB9423EFC13C75850A587E9FB486DB1B4)] [added: Securities](#id101d1fa5bd94d659e900a3dbd836cf4_34)] | [removed: [32](#sB9423EFC13C75850A587E9FB486DB1B4)] | [added: | [31](#id101d1fa5bd94d659e900a3dbd836cf4_34) | | |]

| Item 6 | [added: | |] [Selected Financial [removed: Data](#sE4673E5C0FCF506DA601A59082A3C8E6)] [added: Data](#id101d1fa5bd94d659e900a3dbd836cf4_37)] | [removed: [33](#sE4673E5C0FCF506DA601A59082A3C8E6)] | [added: | [31](#id101d1fa5bd94d659e900a3dbd836cf4_37) | | |]

| Item 7 | [added: | |] [Management's Discussion and Analysis of Financial Condition and Results of [removed: Operations](#s2DD7D79D6C5A5DFDA586299C1A29FE6A)] [added: Operations](#id101d1fa5bd94d659e900a3dbd836cf4_40)] | [removed: [34](#s2DD7D79D6C5A5DFDA586299C1A29FE6A)] | [added: | [32](#id101d1fa5bd94d659e900a3dbd836cf4_40) | | |]

| Item 7A | [added: | |] [Quantitative and Qualitative Disclosures About Market [removed: Risk](#sEC81E697602A514D9346FD22D8EA10A4)] [added: Risk](#id101d1fa5bd94d659e900a3dbd836cf4_64)] | [removed: [41](#sEC81E697602A514D9346FD22D8EA10A4)] | [added: | [39](#id101d1fa5bd94d659e900a3dbd836cf4_64) | | |]

| Item 8 | [added: | |] [Financial Statements and Supplementary [removed: Data](#s560BC2F085E05CE79172A0B362282B7E)] [added: Data](#id101d1fa5bd94d659e900a3dbd836cf4_67)] | [removed: [42](#s560BC2F085E05CE79172A0B362282B7E)] | [added: | [40](#id101d1fa5bd94d659e900a3dbd836cf4_67) | | |]

| Item 9 | [added: | |] [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#s9143DD5FEABA5ED1BC4D36B24E3D9699)] [added: Disclosure](#id101d1fa5bd94d659e900a3dbd836cf4_181)] | [removed: [71](#s9143DD5FEABA5ED1BC4D36B24E3D9699)] | [added: | [70](#id101d1fa5bd94d659e900a3dbd836cf4_181) | | |]

| Item 9A | [added: | |] [Controls and [removed: Procedures](#s05844F26575B552C970541E2BD67F63C)] [added: Procedures](#id101d1fa5bd94d659e900a3dbd836cf4_184)] | [removed: [71](#s05844F26575B552C970541E2BD67F63C)] | [added: | [70](#id101d1fa5bd94d659e900a3dbd836cf4_184) | | |]

| Item 9B | [added: | |] [Other [removed: Information](#s21EBFE828FE95A70A1150AC01A9ADF20)] [added: Information](#id101d1fa5bd94d659e900a3dbd836cf4_187)] | [removed: [71](#s21EBFE828FE95A70A1150AC01A9ADF20)] | [added: | [70](#id101d1fa5bd94d659e900a3dbd836cf4_187) | | |]

| Item 10 | [added: | |] [Directors, Executive Officers and Corporate [removed: Governance](#sBCBBF84DEF865C3ABF0C7CCBDE8872F4)] [added: Governance](#id101d1fa5bd94d659e900a3dbd836cf4_193)] | [removed: [71](#sBCBBF84DEF865C3ABF0C7CCBDE8872F4)] | [added: | [70](#id101d1fa5bd94d659e900a3dbd836cf4_193) | | |]

| Item 11 | [added: | |] [Executive [removed: Compensation](#s642BD891C023510C86D35C24C6A91EA1)] [added: Compensation](#id101d1fa5bd94d659e900a3dbd836cf4_196)] | [removed: [71](#s642BD891C023510C86D35C24C6A91EA1)] | [added: | [70](#id101d1fa5bd94d659e900a3dbd836cf4_196) | | |]

| Item 12 | [added: | |] [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#sA09009FA5BD954BE8424317213F05CE9)] [added: Matters](#id101d1fa5bd94d659e900a3dbd836cf4_199)] | [removed: [72](#sA09009FA5BD954BE8424317213F05CE9)] | [added: | [71](#id101d1fa5bd94d659e900a3dbd836cf4_199) | | |]

| Item 13 | [added: | |] [Certain Relationships and Related Transactions, and Director [removed: Independence](#sDBC369B5E6E251E6A14EE9443774A024)] [added: Independence](#id101d1fa5bd94d659e900a3dbd836cf4_202)] | [removed: [72](#sDBC369B5E6E251E6A14EE9443774A024)] | [added: | [71](#id101d1fa5bd94d659e900a3dbd836cf4_202) | | |]

| Item 14 | [added: | |] [Principal Accounting Fees and [removed: Services](#s71F8C714A06B5D9DA9CC2E168DF42B9B)] [added: Services](#id101d1fa5bd94d659e900a3dbd836cf4_205)] | [removed: [72](#s71F8C714A06B5D9DA9CC2E168DF42B9B)] | [added: | [71](#id101d1fa5bd94d659e900a3dbd836cf4_205) | | |]

| Item 15 | [added: | |] [Exhibits, Financial Statement [removed: Schedules](#s1862EDA1F15856F8A3E44DA02FE335F8)] [added: Schedules](#id101d1fa5bd94d659e900a3dbd836cf4_211)] | [removed: [73](#s1862EDA1F15856F8A3E44DA02FE335F8)] | [added: | [72](#id101d1fa5bd94d659e900a3dbd836cf4_211) | | |]

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Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.

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

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

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

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

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

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| [PART I](#s9E309D61E2F25ADBBFE0FA5CF0E169B0) | | |

| [PART II](#sD3B4FC78DEE55FD285D140FAAB19385A) | | |

| [PART II](#sD3B4FC78DEE55FD285D140FAAB19385A)I | | |

| [PART I](#sD3B4FC78DEE55FD285D140FAAB19385A)V | | |

| | [SIGNATURES](#sE6C348C158EA5C45ADC746FD41A247CC) | [77](#sE6C348C158EA5C45ADC746FD41A247CC) |

[removed: We also lease] [added: As of December 31, 2020, we leased] a total of [added: 15 facilities in 7 countries consisting of] approximately [removed: 200,000] [added: 225,000] square feet of office, research and development and warehousing space and other related [removed: facilities] [added: facilities,] primarily in [removed: the U.S., Europe] [added: North America] and [removed: Canada.][added: Europe.]

We own a 350,000 square foot facility in Acton, MA, which houses both our headquarters and our U.S. manufacturing.

Our owned global headquarters, which encompasses our U.S. manufacturing and office facility in Acton, Massachusetts is approximately 300,000 square feet.

As of February [removed: 20, 2020,] [added: 18, 2021,] there were [removed: 9] [added: 8] registered holders of record of our common stock.

The following graph shows the cumulative total return on $100 invested in each of our common stock, the NASDAQ Composite Index and the NASDAQ Health Care Index for the five-year period beginning on December 31, [removed: 2014,] [added: 2015,] and ending on December 31, [removed: 2019,] [added: 2020,] assuming reinvestment of all dividends.

[removed: ][added: ]

| | [removed: 2014] | | [removed: |] 2015 | | | 2016 | | | 2017 | | | 2018 | | | 2019 | | | [added: 2020 | | |]

The material in this performance graph [removed: is not soliciting material, is] [added: shall] not [added: be] deemed [added: to be] filed with the SEC and is not incorporated by reference in any filing of Insulet Corporation under the Securities Act of 1933, as amended or the Securities Exchange Act of 1934, as amended, whether made on, before or after the date of this filing and irrespective of any general incorporation language in such filing.

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| 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 | |

The number of beneficial stockholders of our shares is greater than the number of stockholders of record.

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| Insulet Corporation | $ | 100 | | $ | 82 | | $ | 82 | | $ | 150 | | $ | 172 | | $ | 372 | |

| NASDAQ Composite | $ | 100 | | $ | 106 | | $ | 114 | | $ | 146 | | $ | 140 | | $ | 189 | |

| NASDAQ Health Care | $ | 100 | | $ | 107 | | $ | 89 | | $ | 108 | | $ | 103 | | $ | 130 | |

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

The following table presents selected financial and other data for Insulet Corporation.

The consolidated statement of operations data set forth below for 2019, 2018 and 2017, and the consolidated balance sheet data as of December 31, 2019 and December 31, 2018, are derived from our audited consolidated financial statements included elsewhere in this annual report.

The consolidated statement of operations data for 2016 and 2015 and the consolidated balance sheet data as of December 31, 2017, December 31, 2016 and December 31, 2015 are derived from our audited consolidated financial statements that are not included in this annual report.

The selected historical financial data presented below should be read in conjunction with our consolidated financial statements and accompanying notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this annual report.

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| | Years Ended December 31, | | | | | | | | | | | | | | | | | | |

| (in millions, except per share data) | 2019 | | | | 2018 | | | | 2017 | | | | 2016 | | | | 2015 | | |

| Consolidated Statement of Operations Data: | | | | | | | | | | | | | | | | | | | |

| Revenue | $ | 738.2 | | | $ | 563.8 | | | $ | 463.8 | | | $ | 367.0 | | | $ | 263.9 | |

| Gross profit | $ | 480.3 | | | $ | 370.2 | | | $ | 277.2 | | | $ | 211.1 | | | $ | 133.3 | |

| Operating income (loss) (1) | $ | 50.0 | | | $ | 27.4 | | | $ | (7.4 | ) | | $ | (10.7 | ) | | $ | (48.7 | ) |

| Income (loss) from continuing operations (2) | $ | 11.6 | | | $ | 3.3 | | | $ | (26.8 | ) | | $ | (27.2 | ) | | $ | (61.6 | ) |

| Income (loss) from continuing operations per share: | | | | | | | | | | | | | | | | | | | |

| Basic | $ | 0.19 | | | $ | 0.06 | | | $ | (0.46 | ) | | $ | (0.48 | ) | | $ | (1.08 | ) |

| Diluted | $ | 0.19 | | | $ | 0.05 | | | $ | (0.46 | ) | | $ | (0.48 | ) | | $ | (1.08 | ) |

| Weighted-average number of shares: | | | | | | | | | | | | | | | | | | | |

| Basic | 60.6 | | | | 58.9 | | | | 58.0 | | | | 57.3 | | | | 56.8 | | |

| Diluted | 62.3 | | | | 61.0 | | | | 58.0 | | | | 57.3 | | | | 56.8 | | |

| Consolidated Balance Sheet Data: | | | | | | | | | | | | | | | | | | | |

| Total assets | $ | 1,142.9 | | | $ | 928.7 | | | $ | 816.7 | | | $ | 456.6 | | | $ | 275.1 | |

| Convertible debt, net | $ | 887.9 | | | $ | 592.0 | | | $ | 566.2 | | | $ | 332.8 | | | $ | 172.0 | |

| Shareholders’ equity | $ | 75.9 | | | $ | 212.1 | | | $ | 158.5 | | | $ | 63.2 | | | $ | 34.1 | |

(1) 2018 includes a charge of $12.6 million for severance costs associated with the retirement of the Company’s former CEO, of which $8.2 million represented stock-based compensation expense resulting from the accelerated vesting of equity awards.

(2) 2019 includes an $8.7 million loss on extinguishment of debt.

Our financial statements as of December 31, [removed: 2019] [added: 2020] and [removed: 2018] [added: 2019] and for each of the three years in the period ended December 31, [removed: 2019,] [added: 2020,] and the Report of the Registered Independent Public Accounting Firm are included in this report as listed in the index.

| INDEX TO CONSOLIDATED FINANCIAL STATEMENTS | | [added: | | | |]

| [Report of Independent Registered Public Accounting [removed: Firm](#s12B9CB1AFF555041B49BA509CD365A40)] [added: Firm](#id101d1fa5bd94d659e900a3dbd836cf4_70)] | [removed: [43](#s12B9CB1AFF555041B49BA509CD365A40)] | [added: | [41](#id101d1fa5bd94d659e900a3dbd836cf4_70) | | |]

| Consolidated Balance Sheets as of December 31, [removed: 2019] [added: 2020] and [removed: 2018] [added: 2019] | [removed: [45](#s0B69F5B8B8375AE69A68448AD3677375)] | [added: | [43](#id101d1fa5bd94d659e900a3dbd836cf4_73) | | |]

| Consolidated Statements of [removed: Operations] [added: Income] for the Years ended December 31, [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017] [added: 2018] | [removed: [46](#s2522917572B1530E91C9154BC563569A)] | [added: | [44](#id101d1fa5bd94d659e900a3dbd836cf4_79) | | |]

| [Consolidated Statements of Comprehensive [removed: I](#s81CDC1964B545524AC6D483252F4E980)ncome (Loss)] [added: I](#id101d1fa5bd94d659e900a3dbd836cf4_82)ncome] for the Years Ended December 31, [removed: 2019, 2018] [added: 2020, 2019] and [removed: 2017] [added: 2018] | [removed: [47](#s81CDC1964B545524AC6D483252F4E980)] | [added: | [45](#id101d1fa5bd94d659e900a3dbd836cf4_82) | | |]

| [Consolidated Statements of Stockholders’ Equity for the Years ended December [removed: 31, 201](#sB29B9327E2C856EDB0809CB83FB3AF2D)9, 2018] [added: 31,](#id101d1fa5bd94d659e900a3dbd836cf4_85) 2020, 2019] and [removed: 2017] [added: 2018] | [removed: [48](#sB29B9327E2C856EDB0809CB83FB3AF2D)] | [added: | [46](#id101d1fa5bd94d659e900a3dbd836cf4_85) | | |]

| [Consolidated Statements of Cash Flows for the Years ended December [removed: 31, 201](#sE90B94BE4BA8504FB4A25FFC32AF780E)9, 2018] [added: 31,](#id101d1fa5bd94d659e900a3dbd836cf4_91) 2020, 2019] and [removed: 2017] [added: 2018] | [removed: [49](#sE90B94BE4BA8504FB4A25FFC32AF780E)] | [added: | [47](#id101d1fa5bd94d659e900a3dbd836cf4_91) | | |]

| [Notes to Consolidated Financial [removed: Statements](#s6735AAEE849A516E8E8B230C751FAFE4)] [added: Statements](#id101d1fa5bd94d659e900a3dbd836cf4_94)] | [removed: [50](#s6735AAEE849A516E8E8B230C751FAFE4)] | [added: | [48](#id101d1fa5bd94d659e900a3dbd836cf4_94) | | |]

We have audited the accompanying consolidated balance sheets of Insulet Corporation (a Delaware corporation) and subsidiaries (the “Company”) as of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] and the related consolidated statements of [removed: operations,] [added: income,] comprehensive [removed: income (loss),] [added: income,] changes in stockholders’ equity, and cash flows for each of the three years in the period ended December 31, [removed: 2019,] [added: 2020,] and the related notes and [removed: schedule] [added: financial statement schedules 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: 2019,] [added: 2020,] based on criteria established in the 2013 Internal [removed: Control-Integrated] [added: 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: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2019] [added: 2020] in conformity with accounting principles generally accepted in the United States of America.

Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2019,] [added: 2020,] based on criteria established in the 2013 Internal [removed: Control-Integrated] [added: Control*—*Integrated] Framework issued by COSO.

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

The critical audit [removed: matters] [added: matter] communicated below [removed: are matters] [added: is a matter] arising from the current period audit of the financial statements that [removed: were] [added: was] communicated or required to be communicated to the audit committee and that: (1) [removed: relate] [added: relates] to accounts or disclosures that [removed: 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 [added: we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.]

As described in Note 4 to the consolidated financial statements, the Company’s revenue from drug delivery was [removed: $64.7] [added: $69.5] million for the year ended December 31, [removed: 2019.][added: 2020.]

[removed: | • |] [added: -] We tested the design and operating effectiveness of controls relating to Management’s estimate of the measure of progress. [removed: |]

[removed: | • |] [added: -] For the measure of progress, we inspected evidence related to the cost and length of the production cycle. [removed: |]

[removed: | • |] [added: -] For revenue recognized on in-process or finished goods inventory [removed: not yet shipped to the customer] (and the related unbilled receivable), we inspected customer orders, binding customer forecasts, inventory records, and [removed: confirmed inventory quantities directly with] third [removed: parties when applicable. |][added: party shipping documentation.]

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

| (in millions, except share and per share data) | [added: | | 2020 | | | | | |] 2019 | | | | [added: | |] 2018 | | |

| ASSETS | | | | | | | | [added: | | | |]

| Current Assets | | | | | | | | [added: | | | |]

| Cash and cash equivalents | [removed: $] | [removed: 213.7] | [added: $] | [added: 907.2] | [added: | | | |] $ | [removed: 113.9] [added: 213.7] | |

| Short-term investments | [removed: 162.4] | | [added: 40.4] | | [removed: 175.0] | | | [added: | 162.4 | | |]

| Inventories | [removed: 101.0] | | [added: 154.3] | | [removed: 71.4] | | | [added: | 101.0 | | |]

| Prepaid expenses and other current assets | [removed: 31.1] | | [added: 63.0] | | [removed: 24.3] | | | [added: | 44.6 | | |]

| Total current assets | [removed: 591.0] | | [added: 1,248.7] | | [removed: 461.3] | | | [added: | 591.0 | | |]

| Long-term investments | [removed: 58.4] | | [added: —] | | [removed: 140.8] | | | [added: | 58.4 | | |]

| Property, plant and equipment, net | [removed: 399.4] | | [added: 478.7] | | [removed: 258.4] | | | [added: | 399.4 | | |]

| Other intangible assets, net | [removed: 13.2] | | [added: 28.7] | | [removed: 10.4] | | | [added: | 13.2 | | |]

| Goodwill | [removed: 39.8] | | [added: 39.8] | | [removed: 39.6] | | | [added: | 39.8 | | |]

| Other assets | [removed: 41.1] | | [added: 77.0] | | [removed: 18.2] | | | [added: | 41.1 | | |]

| Total assets | [removed: $] | [removed: 1,142.9] | [added: $] | [added: 1,872.9] | [added: | | | |] $ | [removed: 928.7] [added: 1,142.9] | |

| LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | | | | [added: | | | |]

| Current Liabilities | | | | | | | | [added: | | | |]

| Accounts payable | [removed: $] | [removed: 54.5] | [added: $] | [added: 54.1] | [added: | | | |] $ | [removed: 25.5] [added: 54.5] | |

| Accrued expenses and other current liabilities | [removed: 103.2] | | [added: 138.1] | | [removed: 90.2] | | | [added: | 103.2 | | |]

| Total current liabilities | [removed: 157.7] | | [added: 207.8] | | [removed: 115.7] | | | [added: | 157.7 | | |]

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

February 23, 2021

| Accounts receivable trade, net | | | 83.8 | | | | | | 69.3 | | |

| Current portion of long-term debt | | | 15.6 | | | | | | — | | |

| Long-term debt, net | | | 1,043.7 | | | | | | 887.9 | | |

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

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

| Research and development | | | 146.8 | | | | | | 132.3 | | | | | | 94.8 | | |

| Selling, general and administrative | | | 384.0 | | | | | | 298.0 | | | | | | 248.0 | | |

| Interest expense, net | | | (45.1) | | | | | | (27.7) | | | | | | (21.3) | | |

| Other income (expense), net | | | 3.3 | | | | | | 0.9 | | | | | | (0.9) | | |

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

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

| Basic | | | 64,735 | | | | | | 60,594 | | | | | | 58,860 | | |

| Diluted | | | 65,946 | | | | | | 62,304 | | | | | | 61,008 | | |

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

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

| Net income | | | $ | 6.8 | | | | | $ | 11.6 | | | | | $ | 3.3 | |

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

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

| (dollars in millions) | | | Shares (in thousands) | | | | | | Amount | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Adoption of ASU 2016-13 (Note 1) | | | — | | | | | | — | | | | | | — | | | | | | (1.1) | | | | | | — | | | | | | (1.1) | | |

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

| Stock-based compensation | | | — | | | | | | — | | | | | | 35.9 | | | | | | — | | | | | | — | | | | | | 35.9 | | |

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

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

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

| Net income | | | $ | 6.8 | | | | | $ | 11.6 | | | | | $ | 3.3 | |

| Accounts receivable | | | (15.6) | | | | | | (10.8) | | | | | | (14.6) | | |

| Accounts payable | | | 7.1 | | | | | | 25.6 | | | | | | (5.4) | | |

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

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

| Proceeds from equipment financing | | | 60.0 | | | | | | — | | | | | | — | | |

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

| | |

| --- | --- |

we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

Our audit procedures included, but were not limited to, the following:

*Convertible Debt Offering and Note Repurchase*

As described in Note 12 to the consolidated financial statements, the Company completed a private placement offering of $800 million in 0.375% Convertible Senior Notes (the “New Notes”), with the proceeds partially used to repurchase the previously outstanding 1.25% Convertible Senior Notes (the “Existing Notes”).

We identified these transactions as a critical audit matter.

The principal considerations for our determination that this matter is a critical audit matter are as follows.

Accounting for the convertible debt offering and the repurchase of the Existing Notes was a significant unusual transaction that required extensive audit effort.

This included the involvement of technical accounting specialists to evaluate Management’s conclusions surrounding the bifurcation of the notes between debt and equity and the extinguishment conclusion for the repurchase of the Existing Notes.

Additionally, valuation specialists were included to determine the fair value of the equity component of the New Notes and the fair value of the Existing Notes utilized in the determination of the loss on extinguishment.

This included the evaluation of the market yield input, which was derived using a Binomial Option Pricing Model.

| • | We tested the control design and operating effectiveness related to the accounting for the transaction including Management’s evaluation of the qualifications of specialists and review of the work performed by the specialists. |

| • | We traced all key terms, and amounts to source documents, including the related offering memorandums and purchase agreements. |

| • | We supplemented the engagement team with technical accounting specialists to confirm Management’s accounting conclusions including the determination that the New Notes be bifurcated between debt and equity as well as the determination that the repurchase of a portion of the Existing Notes be accounted for as an extinguishment of debt. |

| • | With the assistance of valuation professionals with specialized skills and knowledge, we tested Management’s valuation of both the New Notes and the Existing Notes which included a recalculation of the related amounts and an assessment of the appropriateness of the methodology, inputs, and assumptions used. |

February 25, 2020

| | | | | | | | |

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

| Accounts receivable trade, less allowance for doubtful accounts of $3.8 and $3.6 | 69.3 | | | | 63.3 | | |

| Unbilled receivable | 13.5 | | | | 13.4 | | |

| Convertible debt, net | 887.9 | | | | 592.0 | | |

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

| Operating expenses: | | | | | | | | | | | |

| Research and development | 129.7 | | | | 90.5 | | | | 75.7 | | |

| Sales and marketing | 185.1 | | | | 146.2 | | | | 124.2 | | |

| General and administrative | 115.5 | | | | 106.1 | | | | 84.7 | | |

| Total operating expenses | 430.3 | | | | 342.8 | | | | 284.6 | | |

| Interest and other income, net | 7.8 | | | | 6.7 | | | | 2.6 | | |

| Basic | 60,593,846 | | | | 58,859,574 | | | | 58,003,434 | | |

| Diluted | 62,304,348 | | | | 61,008,024 | | | | 58,003,434 | | |

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

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

| (in millions, except share data) | Shares | | | Amount | | | | | | | | | | | | | | | | | | |

| Balance, December 31, 2016 | 57,457,967 | | | $ | 0.1 | | | $ | 744.2 | | | $ | (680.5 | ) | | $ | (0.7 | ) | | $ | 63.1 | |

| Net loss | — | | | — | | | | — | | | | (26.8 | | ) | | — | | | | (26.8 | | ) |

| Conversion feature of 0.375% Notes, net of issuance costs | — | | | — | | | | 207.8 | | | | — | | | | — | | | | 207.8 | | |

| Extinguishment of conversion feature on 1.25% Notes, net of issuance costs | — | | | — | | | | (642.3 | | ) | | — | | | | — | | | | (642.3 | | ) |

| Stock-based compensation expense | 28.7 | | | | 37.5 | | | | 31.9 | | |

| Accounts and unbilled receivable | (10.9 | | ) | | (22.9 | | ) | | (26.3 | | ) |

[removed: Disclosure] [added: *Disclosure] Controls and [removed: Procedures][added: Procedures*]

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: 2019.][added: 2020.]

Based on the evaluation of our disclosure controls and procedures as of December 31, [removed: 2019,] [added: 2020,] 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.

[removed: Changes] [added: *Changes] in Internal Control Over Financial [removed: Reporting][added: Reporting*]

There were no changes in our internal control over financial reporting during the three months ended December 31, [removed: 2019] [added: 2020] that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

[removed: Management’s] [added: *Management’s] Annual Report on Internal Control Over Financial [removed: Reporting][added: Reporting*]

Our management assessed the effectiveness of our internal control over financial reporting as of December 31, [removed: 2019.][added: 2020.]

Based on our assessment, we believe that our internal controls over financial reporting were effective as of December 31, [removed: 2019.][added: 2020.]

The effectiveness of our internal control over financial reporting as of December 31, [removed: 2019] [added: 2020] 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: 2020] [added: 2021] Annual Meeting of Stockholders (the “Proxy Statement”) and is incorporated herein by reference.

[removed: Securities] [added: *Securities] Authorized for Issuance Under Equity Compensation [removed: Plans][added: Plans*]

The following table sets forth information regarding securities authorized for issuance under our equity compensation plans as of December 31, [removed: 2019.][added: 2020.]

| Plan Category | [added: | |] Number of securities to [removed: be issued] [added: be issued] upon exercise [removed: of outstanding options, warrants] [added: of outstanding options, warrants] and [removed: rights (a)] [added: rights (a)] | | | [added: | | |] Weighted [removed: average exercise] [added: average exercise] price [removed: of outstanding options, warrants] [added: of outstanding options, warrants] and [removed: rights (b)] [added: rights (b)] | | | | [added: | |] Number of [removed: securities remaining] [added: securities remaining] available [removed: for future issuance (excluding securities reflected] [added: for future issuance (excluding securities reflected] in column [removed: (a)) (c)] [added: (a)) (c)] | | | [added: | | |]

| Equity compensation plans [added: not] approved by security holders [removed: (1)] [added: (3)] | [removed: 1,246,226] | | [added: 112,436] | [added: | | | | |] $ | [removed: 49.19] [added: 33.90] | | | [removed: 3,936,268] | | [removed: (2)] [added: —] | [added: | | | | |]

| Equity compensation plans [removed: not] approved by security holders [removed: (3)] [added: (1)] | [removed: 483,286] | | [added: 966,052] | [added: | | | | |] $ | [removed: 35.59] [added: 60.79] | | | [removed: —] | | [added: 3,624,340] | [added: | | (2) | | |]

(1) Includes our 2017 [removed: Stock Option and Incentive] Plan and our [removed: Amended and Restated] 2007 [removed: Stock Option and Incentive] Plan.

As of December 31, [removed: 2019, 651,443] [added: 2020, 489,776] 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: $49.19.][added: $60.79.]

[removed: | • |] [added: -] one inducement grant of 499,468 shares of non-qualified stock option awards made to [added: the Company’s former CEO] Patrick J. [removed: Sullivan in September 2014 (109,468 of which have been exercised as of December 31, 2019); |]

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

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

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

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

(2) The shares available for future issuance are under our 2017 Plan, which includes shares related to awards outstanding under the 2007 Plan that are terminated by expiration, forfeiture or cancellation.

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

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

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

| Total | 1,729,512 | | | $ | 45.39 | | | 3,936,268 | | |

(2) Includes 3,936,268 shares available for future issuance under our 2017 Stock Option and Incentive Plan.

| | |

| --- | --- |

| • | one inducement grant of 30,511 non-qualified stock options made to Michael Spears (17,161 of which have been exercised as of December 31, 2019) upon being hired by us in July 2015. |

| Number | [added: | |] Description | [added: | |]

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

| 3.2 | [added: | |] [Amended and Restated By-laws of the Registrant (Incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K, filed February 26, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000081/podd-2016x02x26xexx31.htm) | [added: | |]

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

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

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

| 4.4 | [added: | |] [Indenture, dated as of September 6, 2019, between Insulet Corporation and Wells Fargo Bank, National Association, as Trustee (Incorporated by reference to Exhibit 4.1 to our Current Report on Form 8-K filed September 9, 2019).](http://www.sec.gov/Archives/edgar/data/1145197/000119312519240972/d766132dex41.htm) | [added: | |]

| 4.5 | [added: | |] [Form of 0.375% Convertible Notes due 2026 (included in Exhibit 4.1 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2019, filed November 5, 2019)](http://www.sec.gov/Archives/edgar/data/1145197/000119312519240972/d766132dex41.htm) | [added: | |]

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

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

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

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

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

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

| 10.7* | [added: | |] [Form of Insulet Corporation 2017 Stock Option and Incentive Plan Restricted Stock Unit Agreement for Directors (Incorporated by reference to Exhibit 10.3 to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2017, filed August 4, 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000013/podd-exx103_20170630x10q.htm) | [added: | |]

| 10.8* | [added: | |] [Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Appendix A to our Definitive Proxy Statement on Schedule 14A filed on April 2, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000119312515117872/d864077ddef14a.htm#toc864077_12) | [added: | |]

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

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

| 10.11* | [added: | |] [Form of Executive Officer 3 Year Performance Vesting Restricted Stock Unit Agreement under the 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 March 31, 2017, filed May 9, 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000009/podd-exx103_201733110q.htm) | [added: | |]

| 10.12* | [added: | |] [Form of Vice President 3 Year Performance Vesting Restricted Stock Unit Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.4 to our Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2017, filed May 9, 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000009/podd-exx104_2017331x10q.htm) | [added: | |]

| 10.13* | [added: | |] [Form of Executive Officer Cliff Vesting Performance Restricted Stock Unit Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.5 to our Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2017, filed May 9, 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000009/podd-exx105_2017331x10q.htm) | [added: | |]

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

| 10.15* | [added: | |] [Form of Executive Officer 3 Year Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.7 to our Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2017, filed May 9, 2017)](http://www.sec.gov/Archives/edgar/data/1145197/000114519717000009/podd-exx107_2017331x10q.htm) | [added: | |]

| 10.16* | [added: | |] [Form of International Non-Qualified Stock Option Agreement under the Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2016, filed August 4, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000094/podd-exx101_20160630x10q.htm) | [added: | |]

| 10.17* | [added: | |] [Form of Non-Qualified Stock Option Agreement for Non-Employee Directors under the Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.3 to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2016, filed August 4, 2016](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000094/podd-exx103_20160630x10q.htm)) | [added: | |]

| 10.18* | [added: | |] [Form of Vice President Incentive Stock Option Agreement (Three Year Vest) under the Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.4 to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2016, filed August 4, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000094/podd-exx104_20160630x10q.htm) | [added: | |]

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

| 10.20* | [added: | |] [Form of Non-Executive Employee Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.60 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed February 29, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1060_20151231x10k.htm) | [added: | |]

| 10.21* | [added: | |] [Form of Section 16 Officer Time Vesting Restricted Stock Unit Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.61 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed February 29, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1061_20151231x10k.htm) | [added: | |]

| 10.22* | [added: | |] [Form of Section 16 Officer Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.62 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed February 29, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1062_20151231x10k.htm) | [added: | |]

| 10.23* | [added: | |] [Form of Vice President Time Vesting Restricted Stock Unit Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.63 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed February 29, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1063_20151231x10k.htm) | [added: | |]

| 10.24* | [added: | |] [Form of Vice President Incentive Stock Option Agreement under the Insulet Corporation Third Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.64 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, filed February 29, 2016)](http://www.sec.gov/Archives/edgar/data/1145197/000114519716000083/podd-exx1064_20151231x10k.htm) | [added: | |]

| 10.25* | [added: | |] [Form of Canada Non-Qualified Stock Option Agreement for Company Employees under the Insulet Corporation Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2015, filed August 12, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000059/podd-ex101_20150630x10q.htm) | [added: | |]

| 10.26* | [added: | |] [Form of Canada Time Vesting Restricted Stock Unit Agreement under the Insulet Corporation Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.2 to our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2015, filed August 12, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000059/podd-ex102_20150630x10q.htm) | [added: | |]

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

| 10.28* | [added: | |] [Form of Incentive Stock Option Agreement under the Second Amended and Restated 2007 Stock Option and Incentive Plan - 2015 Sales Plan (Incorporated by reference to Exhibit 10.51 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2014, filed February 26, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000020/poddex1051_2014311210k.htm) | [added: | |]

| 10.29* | [added: | |] [Form of Non-Qualified Stock Option Agreement for Shacey Petrovic under the Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.53 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2014, filed February 26, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000020/poddex1053_2014123110k.htm) | [added: | |]

| 10.30* | [added: | |] [Form of UK Non-Qualified Stock Option Agreement for Employees at the Vice President Level and Above under the Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.56 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2014, filed February 26, 2015)](http://www.sec.gov/Archives/edgar/data/1145197/000114519715000020/poddex1056_2014123110k.htm) | [added: | |]

| 10.31* | [added: | |] [Form of Non-Qualified Stock Option Agreement for Patrick J. Sullivan under the Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2014, filed November 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex101_20140930x10q.htm) | [added: | |]

| 10.32* | [added: | |] [Form of Non-Qualified Stock Option Agreement for Company Employees under the Second Amended and Restated 2007 Stock Option and Incentive Plan (Incorporated by reference to Exhibit 10.4 to our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2014, filed November 5, 2014)](http://www.sec.gov/Archives/edgar/data/1145197/000114519714000055/podd-ex104_20140930x10q.htm) | [added: | |]

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| | [added: | |] INSULET CORPORATION (Registrant) | [added: | |]

| February [removed: 25, 2020] [added: 23, 2021] | [added: | |] /s/ Shacey Petrovic | [added: | |]

| | [added: | |] Shacey Petrovic | [added: | |]

| | [added: | |] Chief Executive Officer (Principal Executive Officer) | [added: | |]

| February [removed: 25, 2020] [added: 23, 2021] | [added: | |] /s/ Wayde McMillan | [added: | |]

| | [added: | |] Wayde McMillan | [added: | |]

| | [added: | |] Chief Financial Officer (Principal Financial Officer) | [added: | |]

Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant and in the capacities on February [removed: 25, 2020.][added: 23, 2021.]

| Signature | | [added: | | | |] Title | [added: | |]

| /s/ Shacey Petrovic | | [added: | | | |] Chief Executive Officer | [added: | |]

| Shacey Petrovic | | [added: | | | |] (Principal Executive Officer) | [added: | |]

| /s/ Wayde McMillan | | [added: | | | |] Chief Financial Officer | [added: | |]

| Wayde McMillan | | [added: | | | |] (Principal Financial Officer) | [added: | |]

| /s/ Lauren Budden | | [added: | | | |] Chief Accounting Officer and Controller | [added: | |]

| Lauren Budden | | [added: | | | |] (Principal Accounting Officer) | [added: | |]

| /s/ Sally Crawford | | | [added: | | | | | |]

| Sally Crawford | | [added: | | | |] Director | [added: | |]

| /s/ John A. Fallon, M.D. | | | [added: | | | | | |]

| John A. Fallon, M.D. | | [added: | | | |] Director | [added: | |]

| /s/ James R. Hollingshead | | | [added: | | | | | |]

| James R. Hollingshead | | [added: | | | |] Director | [added: | |]

| /s/ Jessica Hopfield | | | [added: | | | | | |]

| Jessica Hopfield | | [added: | | | |] Director | [added: | |]

| /s/ David A. Lemoine | | | [added: | | | | | |]

| David A. Lemoine | | [added: | | | |] Director | [added: | |]

| /s/ Michael R. Minogue | | | [added: | | | | | |]

| Michael R. Minogue | | [added: | | | |] Director | [added: | |]

| /s/ Corinne H. Nevinny | | | [added: | | | | | |]

| Corinne H. Nevinny | | [added: | | | |] Director | [added: | |]

| /s/ Timothy J. Scannell | | | [added: | | | | | |]

| Timothy J. Scannell | | [added: | | | |] Director | [added: | |]

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| /s/ Wayne A.I. Frederick, M.D. | | | | | | | | |

| Wayne A.I. Frederick, M.D. | | | | | | Director | | |

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