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Item 1. Business

2024-02-23 compared with 2023-02-24 · 160 added, 183 removed, 260 unchanged (57% of the section changed)

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

The Omnipod System includes:

the Omnipod Insulin Management System (“Classic Omnipod”), the Omnipod DASH ® Insulin Management System (“Omnipod DASH”), and the Omnipod ® 5 Automated Insulin Delivery System (“Omnipod 5”).

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

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

The Omnipod platform includes:

the Omnipod ® 5 Automated Insulin Delivery System (“Omnipod 5”), the Omnipod DASH ® Insulin Management System (“Omnipod DASH”), the Omnipod Insulin Management System (“Classic Omnipod”) and our latest innovation, Omnipod GO TM , which received U.S.

Food and Drug Administration (“FDA”) clearance in 2023.

We also produce pods for Amgen for use in the Neulasta ® Onpro ® kit, a delivery system for Amgen’s Neulasta to help reduce the risk of infection after intense chemotherapy.

Market Opportunity:

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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.

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

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

We estimate that approximately six million people have insulin-intensive type 2 diabetes in the countries we currently serve.

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

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

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

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and international insulin-intensive type 2 diabetes population use insulin pump therapy.

We believe these factors present a significant available market for the Omnipod System globally.

We believe these factors present a significant available market for our Omnipod platform globally.

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

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

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

Additionally, the time spent managing fluctuations in blood glucose levels and the fear associated with hypoglycemia can be incredibly stressful for individuals with diabetes and their families.

Current Insulin Therapy

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

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

People with insulin-dependent diabetes need a continuous supply of insulin, known as basal insulin, for background metabolic needs.

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

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

There are two primary types of insulin therapy practiced today:

multiple daily injections (“MDI”) therapy using syringes or insulin pens and pump therapy using insulin pumps.

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

multiple daily injection (“MDI”) therapy using syringes or insulin pens and pump therapy using insulin pumps.

MDI therapy involves injecting fast-acting insulin before meals (bolus) to lower blood glucose levels to a healthy range.

MDI therapy may also require a separate injection of a long-acting (basal) insulin, to control glucose levels between meals;

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Our Solution:

The Omnipod System

The Omnipod System is a continuous insulin delivery system that provides all the benefits of insulin pump therapy in a unique way.

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

Omnipod DASH Omnipod 5

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

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

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

The Pod delivers insulin into the body through a small flexible tube (called a cannula);

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

Additionally, Omnipod 5 is interoperable with a third-party continuous glucose monitor (“CGM”) sold separately that obtains glucose values and integrates with the Pod.

Further, we have partnered with Glooko Inc.

(“Glooko”) to connect our Omnipod System user data with Glooko’s comprehensive diabetes data management system (including Glooko and Diasend in selected regions).

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

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

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

In the U.S., the PDM has nightly automatic data uploads providing users and their clinicians with cloud access to data, and enhancements for pushing software updates wirelessly to users.

The Omnipod Platform

The Omnipod platform offers continuous insulin delivery that provides all the benefits of insulin pump therapy in a unique way without the need for external tubing required with conventional pumps.

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

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

Omnipod 5 Omnipod DASH Omnipod GO

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

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

full market release.

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

Omnipod 5 includes a proprietary AID algorithm embedded in the Pod.

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

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

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

The Pod is controllable by an Insulet-provided handheld device (Controller) or a user-downloaded Android app, which allows for full compatible smartphone control.

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

We expect to launch the iOS app in 2024.

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

connection if established.

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

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

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

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

Omnipod DASH provides continuous insulin delivery at preset rates, eliminating the need for individual insulin injections.

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Omnipod DASH communicates wirelessly, provides for virtually pain-free automated cannula insertion, and eliminates the need for MDI therapy or the use of pump and tubing.

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

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

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

Omnipod 5, which builds on our Omnipod DASH platform, was cleared by the U.S.

Food and Drug Administration (“FDA”) in January 2022.

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

full market release.

In September 2022, we received CE Mark approval for Omnipod 5 under the European Union Medical Device Regulation (“MDR”).

Omnipod 5 includes an AID algorithm that is located on the Pod.

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

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

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

The Pod is controllable by an Insulet-provided handheld device (Controller) or a user-downloaded Android app, which allows for full compatible smartphone control.

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

The Pod currently integrates with a CGM manufactured by Dexcom, Inc.

Subsequent to the launch of Omnipod 5, the vast majority of our customer base is no longer using our Classic Omnipod product.

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

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

Omnipod Classic

Following the launch of Omnipod 5, the vast majority of our customer base is no longer using our Classic Omnipod product.

Accordingly, we are phasing-out our Classic Omnipod product in the U.S.

and no longer guarantee the availability of its supplies.

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

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

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

Omnipod GO has been cleared for use with the following U-100 insulins:

NovoLog®, Fiasp®, Humalog®, Admelog®, and Lyumjev®.

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

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

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

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

Data Management

We have partnered with Glooko Inc.

(“Glooko”) to connect user data with Glooko’s comprehensive diabetes data management system (including Glooko and Diasend in selected regions).

Paramount to our ability to deliver full compatible smartphone control is our commitment to cybersecurity and information security.

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

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

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

With the DTSec and ISO certifications, Insulet is globally recognized for incorporating the highest standards for cybersecurity and information security and safety, including secure data transfer between the Pod and PDM, as well as secure cloud storage.

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

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

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

Cyber Essentials.

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

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

“Cybersecurity” for additional information.

Third-Party Reimbursement

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

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

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

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

The Omnipod System’s unique patented design allows us to provide pump therapy at a relatively low or no up-front investment, which reduces the risk to third-party payors in the U.S.

In certain international locations in which we sell through a distributor or intermediary, our distribution partners and local intermediaries establish appropriate reimbursement contracts with healthcare systems in those countries and provinces.

Our Omnipod platform’s unique patented

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

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

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

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

Markets and Distribution Methods

The Omnipod System is currently available in the following 24 countries:

Australia Finland Italy Sweden

Austria France Kuwait Switzerland

Belgium Germany Netherlands Turkey

Canada Greece Norway United Arab Emirates

Croatia Iceland Qatar United Kingdom

Denmark Israel Saudi Arabia United States

We sell the Omnipod System directly to consumers, through distribution partners and in the U.S.

also through the pharmacy channel.

For the year ended December 31, 2022, 84% of our Omnipod System sales were through intermediaries.

The Omnipod System is also marketed to physicians.

Omnipod products are currently available in the following 25 countries:

Australia Cyprus Greece Netherlands Switzerland

Austria Denmark Iceland Norway Turkey

Belgium Finland Israel Qatar United Arab Emirates

Canada France Italy Saudi Arabia United Kingdom

Croatia Germany Kuwait Sweden United States

We sell Omnipod products directly to consumers, through distribution partners and in the U.S., also through the pharmacy channel.

For the year ended December 31, 2023, 90% of Omnipod product sales globally were through intermediaries.

The percentages of total revenue for customers that represent 10% or more of total revenue was as follows:

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Distributor C 19% 17% 12%

Distributor D 16% * *

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

Our sales and marketing efforts are focused on customer acquisition and retention to meet the user, clinician, and payor demands for the Omnipod System.

We have a comprehensive sales and marketing approach, which communicates the benefits of the Omnipod System to users, physicians and providers.

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

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

This includes three areas of focus:

• Building consumer awareness about the features and benefits that the Omnipod System provides to simplify diabetes management.

• Strengthening physician support by demonstrating clinical evidence of how the Omnipod System improves outcomes and quality of life and providing data and insights to physicians offering diabetes care.

• Providing payors with the clinical and economic justifications for why the Omnipod System offers unique value to the people whom they insure.

We believe that training consumers on how to use the Omnipod System is an important factor to promote successful outcomes and customer retention.

We have streamlined and standardized our training by developing improved online resources and increased our field clinician team to directly train new Omnipod System users.

• Building consumer awareness about the features and benefits that Omnipod products provide to simplify diabetes management.

• Strengthening physician support by demonstrating clinical evidence of how Omnipod products improve outcomes and quality of life and providing data and insights to physicians offering diabetes care.

• Providing payors with the clinical and economic justifications for why Omnipod products offer unique value to the people they insure.

We believe that training consumers on how to use Omnipod products is an important factor to promote successful outcomes and customer retention.

We have streamlined and standardized our training by developing online resources and increased our field clinician team to directly train new users.

We created an online training program for Omnipod customers transitioning to Omnipod DASH or Omnipod 5.

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

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

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

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

The Omnipod System competes for consumers in the insulin delivery market.

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

Our Omnipod platform competes for consumers in the insulin delivery market.

Because most new Omnipod users come from MDI therapy, which currently is the most prevalent method of insulin delivery, we believe that we primarily

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

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

Medtronic historically has held the

majority share of the tubed insulin pump market.

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

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

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

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

Research and Development

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• user choice of sensor and smartphone integrations.

In addition, our research and development efforts are primarily focused on making improvements to the Omnipod System, including adding features and functionality that will deliver increased economic value and convenience to users.

In 2022, we received FDA clearance for Omnipod 5 for individuals aged two years and older with type 1 diabetes and received CE Mark approval for Omnipod 5 under the European Union MDR.

We plan to begin a pivotal trial for Omnipod 5 in 2023 with the goal of expanding Omnipod 5’s indications to individuals with type 2 diabetes.

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

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

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

In addition, our research and development efforts are primarily focused on making improvements to Omnipod 5, including adding features and functionality that will deliver increased economic value and convenience to users.

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

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

We also recently received CE mark approval under the MDR for the added compatibility of Libre 2 Plus with Omnipod 5 for individuals aged two years and older with type 1 diabetes and expect to launch a limited market release of Omnipod 5 with Libre 2 Plus in the U.K.

and the Netherlands in 2024.

We also continue to advance work to improve the Omnipod 5 algorithm and develop next-generation automated insulin delivery products.

In 2023, we began our EVOLUTION feasibility trial in New Zealand to test potential enhancements to the Omnipod 5 algorithm in order to further drive simplicity of use.

We have completed the first round of study, which included testing the system with both type 1 and type 2 users and are in the process of analyzing the data and making modifications for the next round of study.

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

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

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

Manufacturing and Quality Assurance

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

In order to manufacture sufficient volumes at high quality and achieve a cost-effective per unit production price for the Omnipod, we have designed the Omnipod System to be manufactured through automation.

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

The Acton facility increases supply redundancy and adds capacity closer to our North American customer base to support the growth of our business.

We also produce our devices on manufacturing lines at a facility in Kunshan (Shanghai), China operated by a contract manufacturer.

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

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

We also produce our devices on manufacturing lines at a facility in China operated by a contract manufacturer.

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

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

Additionally, in 2022, we broke ground on a new manufacturing plant in Malaysia to support our international expansion strategy and further ensure product supply.

In December 2023, we completed construction of our new manufacturing plant in Malaysia to support our international expansion strategy and further ensure product supply.

We expect to begin production at this facility in 2024.

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

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

Raw Materials

We use a broad range of raw materials in the assembly and manufacturing of the Omnipod System.

We use a broad range of raw materials in the assembly and manufacturing of our products.

We purchase our raw materials and select components used in the manufacturing of our products from external suppliers.

We purchase some supplies from a single or limited number of sources for reasons of proprietary know-how, quality assurance, cost-effectiveness, or constraints resulting from regulatory requirements.

We rely on a limited number of suppliers for a certain number of the components and sub-assemblies used in the manufacture of the Omnipod System, including application-specific integrated circuit chips, Bluetooth low-energy chips, and other specialized parts.

We rely on a limited number of suppliers for a certain number of the components and sub-assemblies used in the manufacture of our products, including application-specific integrated circuit chips, Bluetooth low-energy chips, and other specialized parts.

The design of certain components and sub-assemblies (including, in some instances, the raw materials used to manufacture them) is proprietary and the intellectual property rights may be owned exclusively by one party.

In such cases, we are sole-sourced, with the supplier controlling the intellectual property rights.

These sole sourced components are critical to the design and functionality of the Omnipod System.

In the case of sole sourced parts, we manage risk through holding inventory in-house and at the supplier to ensure continuity of supply and lower risk of disruption.

We purchase many of our components and sub-assemblies from manufacturers with whom we are at

least dual sourced.

These sole-sourced components are critical to the design and functionality of our products.

In the case of sole sourced parts, we manage risk

through holding inventory in-house and at the supplier to ensure continuity of supply and lower risk of disruption.

We purchase many of our components and sub-assemblies from manufacturers with whom we are at least dual sourced.

We work closely with all suppliers to ensure continuity of supply while maintaining high quality and reliability.

Quality Assurance

We utilize outside vendors for the supply of components, sub-assemblies, and various services used in the manufacture of the Omnipod System.

Our outside vendors produce the components to our specifications, and they are audited periodically by our Quality Assurance Department to confirm conformity with the specifications, policies, and procedures for the Omnipod System.

Our Quality Assurance Department also inspects and tests the Omnipod System at various steps in the manufacturing cycle to facilitate compliance with our specifications.

We utilize outside vendors for the supply of components, sub-assemblies, and various services used in the manufacture of our products.

Our Quality Assurance Department also inspects and tests our products at various steps in the manufacturing cycle to facilitate compliance with our specifications.

We have received our ISO, European Union MDR, and Medical Device Single Audit Program certifications for our Quality Management System from BSI Group, an accredited Notified Body for CE Marking.

Processes utilized in the manufacture, test, and release of the Omnipod System have been verified and validated as required by the FDA and other regulatory bodies.

Processes utilized in the manufacture, test, and release of our products have been verified and validated as required by the FDA and other regulatory bodies.

As a medical device manufacturer and distributor, our manufacturing facilities and the facilities of our suppliers are subject to periodic inspection by the FDA, certain corresponding state agencies, and other regulatory bodies.

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We also require employees, consultants, and advisers who work on our products to agree to disclose and assign to us all inventions conceived during their work with us that are developed using our property or relate to our business.

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

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

As of December 31, 2023, we had over 700 patents in the United States and in certain other countries, with expiration dates ranging from 2024 through 2043 and had over 500 patent applications pending.

The issued patents and pending patent applications cover, among other things:

• the basic architecture of the Omnipod System, including the pump and the PDM/Controller;

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

• the Omnipod drive system;

• the Omnipod cannula insertion system;

• control features of the Omnipod System and next generation products;

• software, such as algorithms and apps, for controlling the Omnipod System and next generation products;

• various novel aspects of the Omnipod System, potential future generations of Omnipod Systems, and other mechanisms for the delivery of pharmaceuticals.

• software, such as algorithms and apps, for controlling our current and next generation Omnipod products;

• various novel aspects of our current and potential future generations of Omnipod products, and other mechanisms for the delivery of pharmaceuticals.

We have registered various trademarks associated with our business with the United States Patent and Trademark Office on the Principal Register and in other appropriate jurisdictions.

Our trademarks include INSULET TM , OMNIPOD ® , OMNIPOD ® 5 Automated Insulin Delivery System, SIMPLIFY LIFE TM , Omnipod DASH ® , Omnipod DISPLAY ® , Omnipod VIEW TM , SmartAdjust TM , Pod Pals ® , Podder ® , and PodderCentral ® .

Recent Intellectual Property Agreement s

In February 2023, we entered into a Patent Assignment and License Agreement with Bigfoot Biomedical, Inc.

(“Bigfoot”), pursuant to which we acquired approximately 400 patents as well as a significant number of global patent applications, and licensed a large number of additional patents and patent applications on a fully paid-up exclusive or non-exclusive basis.

In October 2022, we entered into a mutual agreement with Medtronic, Inc., not to assert our patents against each other for certain technologies in the field of diabetes.

With certain exclusions, this agreement applies to the companies’ existing products, as well as new products for at least the next seven years.

No payments have been or will be exchanged as part of the agreement.

The agreement replaces and terminates the Settlement and Cross License Agreement, dated September 18, 2013, by and between us and Medtronic.

Our trademarks include INSULET ® , OMNIPOD ® , SIMPLIFY LIFE ® , Omnipod DASH ® , Omnipod GO TM , Omnipod DISPLAY ® , Omnipod VIEW ® , SmartAdjust TM , Pod Pals ® , Podder ® , and PodderCentral ® .

Government Regulation

United States FDA Regulation

The Omnipod System is a medical device subject to extensive and ongoing regulation by the FDA and other federal, state, and local regulatory bodies.

Our products are medical devices that are subject to extensive and ongoing regulation by the FDA and other federal, state, and local regulatory bodies.

FDA regulations govern, among other things, product design and development, preclinical and clinical testing, pre-market clearance or approval, manufacturing, labeling, product storage, advertising and promotion, sales and distribution, post-market adverse event reporting, post-market surveillance, complaint handling, repair or recall of products, and record keeping.

Unless an exemption applies, each medical device we seek to commercially distribute in the United States will require either prior 510(k) clearance or pre-market approval (“PMA”) from the FDA.

A 510(k) pre-market notification filing must contain information establishing that the device to be sold is substantially equivalent to a device commercially distributed prior to May 28, 1976 or to a device that has been determined by the FDA to be substantially equivalent.

Both the 510(k) clearance and PMA processes can be expensive and lengthy and entail significant user fees.

We have obtained 510(k) clearance for the Omnipod, Omnipod DASH, and Omnipod 5 Systems and expect that regulatory approval will be needed for some of our future products.

We have obtained 510(k) clearance for Classic Omnipod, Omnipod DASH, Omnipod 5, and Omnipod GO and expect that regulatory clearances or approvals will be needed

for some of our future products.

In addition, we may be required to obtain a new 510(k) clearance or pre-market approval for significant post-market modifications to our products.

510(k) Clearance .

To obtain 510(k) clearance for any of our potential future devices (or for certain modifications to devices that have previously received 510(k) clearance), we must submit a pre-market notification demonstrating that the proposed device is substantially equivalent to a previously cleared 510(k) device.

The FDA’s 510(k) clearance pathway generally takes three to 12 months from the date the application is completed but can take significantly longer.

A 510(k) application must be supported by extensive data, including technical information, labeling, and potentially clinical data to meet any Special Controls and to demonstrate the safety and effectiveness of the device to the FDA’s satisfaction.

After a medical device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a significant change in its intended use, requires a new 510(k) clearance or, depending on the modification, could require a PMA application.

The FDA requires each manufacturer to make this determination initially, but if the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or PMA is obtained and assess significant regulatory fines or penalties for failure to submit the requisite 510(k) or PMA application(s).

Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, and devices deemed not substantially equivalent to a previously cleared 510(k) device generally require a PMA before they can be commercially distributed.

A PMA application must be supported by extensive data, including technical information, pre-clinical and clinical trials, manufacturing information and labeling, to demonstrate the safety and effectiveness of the device to the FDA’s satisfaction.

After a PMA application is complete, the FDA begins an in-depth review of the submitted information, which generally takes between one and three years, but may take significantly longer.

During this review period, the FDA may request additional information or clarification of information already provided.

Also, during the review period, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the approvability of the device.

The FDA conducts a pre-approval inspection of the manufacturing facility to ensure compliance with Quality System Regulations (“QSR”), which impose elaborate design development, testing, control, documentation, and other quality assurance procedures in the design and manufacturing process.

The FDA may approve a PMA application with post-approval conditions intended to ensure the safety and effectiveness of the device including, among other things, restrictions on labeling, promotion, sale and distribution, and collection of long-term follow-up data from people in the clinical study that supported approval.

Failure to comply with the conditions of approval can result in materially adverse enforcement action, including the loss or withdrawal of the approval.

After PMA, a new PMA application or application supplement may be required in the event of modifications to the device, its labeling, intended use or indication, or its manufacturing process.

PMA supplements often require submission of the same type of information as a PMA application, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA application and may not require as extensive clinical data or the convening of an advisory panel.

Clinical Trials.

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Our clinical trials must be conducted in accordance with FDA regulations and federal and state regulations concerning human subject protection, including informed consent and healthcare privacy.

A clinical trial may be suspended by the FDA or at a

specific site by the relevant IRB at any time for various reasons, including a belief that the risks to the trial participants outweigh the benefits of participation in the clinical trial.

A clinical trial may be suspended by the FDA or at a specific site by the relevant IRB at any time for various reasons, including a belief that the risks to the trial participants outweigh the benefits of participation in the clinical trial.

Even if a clinical trial is completed, the results of our clinical testing may not demonstrate the safety and efficacy of the device or may be equivocal or otherwise insufficient for us to obtain approval of our product.

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• establishment registration and device listing;

• QSR, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during the development and manufacturing process;

• the FDA’s Quality System Regulation (“QSR”), which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during the development and manufacturing process;

• labeling regulations and prohibitions against the promotion of products for uncleared, unapproved or “off-label” uses, and other requirements related to promotional activities;

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If, as a result of these inspections, the FDA determines that our equipment, facilities, laboratories, or processes do not comply with applicable FDA regulations and conditions of product approval, the FDA may seek civil, criminal, or administrative sanctions and/or remedies against us, including the suspension of our manufacturing operations.

Since approval of the Omnipod System, we have been subject to FDA inspections of our facilities on multiple occasions.

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

Other Regulations

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

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

In order to sell our product through the pharmacy channel in the United States, we are required to work with intermediaries who have the appropriate pharmacy license for the applicable market.

In addition, we are subject to certain state laws regarding professional licensure.

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

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

We are also subject to certain state laws regarding professional licensure.

We believe that our certified diabetes educators are in compliance with all such state laws.

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The federal Anti-Kickback Statute has been interpreted to apply to arrangements between drug and medical device manufacturers and suppliers on one hand and prescribers, patients, purchasers, and formulary managers on the other.

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

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

In addition, claims resulting from a violation of the federal Anti-Kickback Statute constitute false or fraudulent claims for purposes of the federal civil False Claims Act discussed below.

Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common business practices from prosecution and administrative sanctions, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration that may be perceived as inducing the prescription, purchase, or recommendation of the Omnipod System may be subject to scrutiny under the law.

For example, we provide the initial training to users necessary for appropriate use of the Omnipod System either through our own diabetes educators or by contracting with outside diabetes educators that have completed a Certified Pod Trainer course.

Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common business practices from prosecution and administrative sanctions, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration that may be perceived as inducing the prescription, purchase, or recommendation of Omnipod products may be subject to scrutiny under the law.

For example, we may provide the initial training to users necessary for appropriate use of our product either through our own diabetes educators or by contracting with outside diabetes educators that have completed a Certified Pod Trainer course.

We compensate outside diabetes educators for their services at contracted rates deemed to be consistent with the market.

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Civil Monetary Penalties Law.

We are subject to the federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transferring of remuneration to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of Medicare or Medicaid payable items or services.

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

Noncompliance can result in significant civil monetary penalties for each wrongful act, assessment of three times the amount claimed for each item or service, and exclusion from the federal healthcare programs.

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Privacy Laws.

Several states have enacted various privacy laws.

At least 15 states have enacted various privacy laws of general applicability over the past several years.

For example, the California Consumer Privacy Act (“CCPA”) is a consumer privacy law, which provides certain privacy rights and consumer protection for residents of the state of California.

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

CPRA enforcement is scheduled to begin on July 1, 2023.

CPRA enforcement is scheduled to begin in March of 2024.

If we fail to comply with these regulations, we could be subject to civil sanctions, including fines and penalties for noncompliance.

Virginia and Colorado have enacted similar laws.

The Consumer Data Protection Act became effective in Virginia on January 1, 2023, and the Colorado Privacy Act is effective July 1, 2023.

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

In addition, general privacy legislation has been filed in Congress, but the final form of the legislation and when it might be enacted is difficult to predict.

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

While some uncertainty exists regarding the future aspects of the ACA, we expect that the ACA will continue to have a significant impact on the delivery of healthcare in the United States and on our business in the near term.

We expect that the ACA will continue to have a significant impact on the delivery of healthcare in the United States and on our business in the near term.

Physician Payments Sunshine Act .

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Certain states’ laws require additional reporting of payments and transfers of value to healthcare providers.

Since these laws and regulations continue to evolve, we lack definitive guidance as to the application of certain key aspects of these laws and regulations as they relate to certain of our arrangements and programs, including those with providers with respect to user training.

respect to user training.

We cannot predict the final form of these regulations or the effect their application will have on us.

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Other countries, such as Switzerland, have voluntarily adopted laws and regulations that mirror those of the European Union with respect to medical devices.

The European Union has adopted numerous directives and standards regulating the design, clinical trials, manufacture, labeling, and adverse event reporting for medical devices, including the Medical Device Directive (“MDD”) and the Medical Device Regulation (“MDR”), which replaced MDD in May 2021.

Devices that comply with the requirements of the MDD will be entitled to bear the CE conformity marking and, accordingly, can be commercially distributed until May 2024, at which time devices must comply with the MDR, unless certain requirements are met that would allow for an extension until December 2027.

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Outside of the European Union, regulatory approval needs to be sought on a country-by-country basis for us to market our products.

We have obtained the right to affix the CE Mark to the Omnipod and Omnipod DASH Systems under the MDD and to the Omnipod 5 System under MDR, which allows us to distribute these products throughout the European Union and in other countries that recognize the CE Mark.

In addition, we have Health Canada approval to sell Classic Omnipod and Omnipod DASH in Canada.

We have obtained the right to affix the CE Mark to Classic Omnipod and Omnipod DASH under the MDD.

We can continue to sell Classic Omnipod through 2027 under MDD in the European Union and in other countries that recognize the CE Mark and are awaiting certification under MDR for Omnipod DASH.

We have obtained the right to affix the CE Mark to Omnipod 5 under MDR, which allows us to distribute it throughout the European Union and in the United Kingdom.

In addition to these countries, Omnipod DASH can be marketed in the Gulf Cooperation Council Countries and in Australia.

We also have Health Canada approval to sell Classic Omnipod and Omnipod DASH in Canada.

A range of anti-bribery and anti-corruption laws, as well as industry specific laws and codes of conduct, apply to the medical device industry and interactions with government officials and entities and healthcare professionals.

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Bribery Act, to any person.

In addition, the European Union Whistleblower Directive (effective in late 2023) and other applicable law around the world impose specific requirements on companies regarding speak up policies and non-retaliation policies.

General Data Protection Regulation.

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If we fail to comply with these standards, we could be subject to criminal penalties and civil sanctions, including fines and penalties for noncompliance.

The European Union has laid out a multi-year plan for additional privacy and data regulation, building upon the GDPR, and has begun to execute on that plan.

For example, the Cybersecurity Directive and the Artificial Intelligence Act have been finalized and will impose additional obligations on businesses generally, including those in the medical device industry.

Human Capital Resources

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We strive to attract and retain the best talent with competitive compensation and benefits, opportunities for growth and development, and a culture that emphasizes fair and equitable treatment.

As of December 31, 2022, we had approximately 2,600 full-time employees, representing a 13% increase over the prior year.

As of December 31, 2023, we had approximately 3,000 full-time employees, representing an 18% increase over the prior year.

Approximately 75% of our employees are located in the United States and the remainder are located in 15 other countries.

To assess and improve employee retention and engagement, we survey employees with the assistance of third-party consultants, and take timely action to address key areas of employee concern.

We conduct engagement surveys to gain valuable insight into our employees’ experience and identify areas for improvement.

In 2022, instead of conducting an engagement survey once per year, we launched ‘Your Voice’ pulse surveys, which are conducted more often, to better understand opportunities to improve our talent management strategy and gain a more dynamic view of our employees’ needs.

Our senior leadership team assesses engagement to understand and identify potential opportunities for improvement.

Our executive leadership team conducts regular Town Hall meetings to ensure our global employees are highly engaged and receive timely business updates.

To assess employee retention and engagement and identify potential opportunities for improvement, we conduct periodic ‘Your Voice’ employee pulse surveys and take timely action to address key areas of employee concern.

Our executive leadership team also conducts regular Town Hall meetings to ensure our global employees are highly engaged and receive timely business updates.

To help our remote employees feel socially connected to their colleagues, we created our “Stay Connected” initiative, which includes virtual meetings with our executive team members.

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Our DEI activities focus on four main areas—Attraction, Talent Development, Culture, and External Engagement—which reflect our commitment to integrating DEI within our business processes.

In 2022, we worked to embed diversity more formally into our talent acquisition process to attract a diverse pool of candidates.

In addition, we launched our flagship diversity training, Conscious Inclusion, to all employees.

Our Employee Resource Groups (“ERGs”) serve as a source of inclusion across the following eight categories:

African Descent, Asian and Pacific Islander, Hispanic/Latin, LGBTQ+, Sustainability, Veterans and First Responders, Women, and Young Professionals.

In 2023, we continued to embed diversity more formally into our talent acquisition process to attract a diverse pool of candidates.

In addition, we continue to provide Conscious Inclusion and Inclusive Hiring diversity training to people managers and employees.

Our Employee Resource Groups (“ERGs”) serve as a source of inclusion across the following nine categories:

African Descent, Asian and Pacific Islander, Hispanic/Latin, LGBTQ+, Sustainability, Veterans and First Responders, Women, Young Professionals, and Jewish Heritage.

These ERGs support the acquisition of diverse talent and are sponsored by senior leaders across our organization.

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All employees who join Insulet undergo a robust onboarding program called RITE Start that introduces our core values of respect, integrity, teamwork, and excellence, and educates new employees about diabetes, our Omnipod products, our business strategy, our culture, and our mission, which is to improve the lives of people with diabetes.

In 2022, we launched our ‘Ignite Your Growth’ career development program to employees across the globe.

We also offer intensive Customer Care New Hire Training and Sales New Hire Training.

In 2022, we launched our ‘Ignite Your Growth’ career development program to employees across the globe and in 2023 we launched our ‘Ignite Your Leadership’ training program to people managers to support the growth and development of our future leaders and build their capabilities.

In addition, we launched LinkedIn Learning to all employees globally providing everyone access to virtual and online learning programs on demand to support their career growth and development.

We also offer training for new managers, resources for our experienced leaders, intensive Customer Care New Hire Training, and Sales New Hire Training.

In addition, employees have access to monthly learning programs and virtual and online learning programs.

Further, during our 2022 annual Compliance Week, employees logged over 7,000 training hours.

We offer leadership development programs to support the growth of our future leaders.

We also offer training for new managers and resources for our experienced leaders.

Additionally, we offer professional certification course reimbursement of up to $3,000 annually and tuition reimbursement of up to $5,250 annually for courses taken in pursuit of an undergraduate degree and up to $10,000 annually for courses taken in pursuit of a graduate degree.

Finally, we offer virtual training programs and employee communications designed to support employees and leaders that take advantage of our flexible work policy, including programs on leading effective remote meetings, managing remotely, and how to leverage collaborative learning tools.

Competitive Pay and Benefits

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We are committed to providing comprehensive benefit options that allow our employees and their families to live healthier and more secure lives.

Our wide-ranging benefits include health insurance, telehealth, prescription drug benefits, dental insurance, vision insurance, 80 hours of COVID-19 paid sick time, accident insurance, critical illness insurance, life insurance, disability insurance, health savings accounts, flexible savings accounts, retirement plans, employee stock purchase plan, legal services, identity theft protection, maternity/paternity leave, and employee assistance program.

In addition, we offer Pod perks, which provides a free Omnipod System, including PDM/Controller and Pods to benefit eligible employees, interns, or dependents;

summer hours;

and a flexible work policy.

In additional to the above, we continued our commitment to flexibility through our Future of Work program.

Our Future of Work program and Global Flexible Working Arrangement Policy are rooted in a “choice with responsibility” philosophy.

Our sustained commitment to flexibility enables access to a broader, more diverse, and more exceptional talent pool.

In addition, we offer Pod perks, which provides a free Omnipod 5 or Omnipod DASH product, including PDM/Controller and Pods to benefit eligible employees, interns, or dependents.

We also offer summer hours and flexible work arrangements, including the opportunity to work remotely, which allows us to access a broader, more diverse, and more exceptional talent pool.

Health and Safety

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In addition to hazard recognition, our workplace health and safety programs cover ergonomics, hearing conservation, fall protection, and accident and injury prevention.

We also have formal plans in place to protect our employee’s safety in the event of an emergency.

We also have formal plans in place to protect our employees' safety in the event of an emergency.

In addition, our Acton, Massachusetts facility maintains an Emergency Action Plan that describes procedures that employees should follow when faced with a variety of unexpected health and safety events.

As part of this initiative, we trained certain employees to use automated external defibrillators, provide first aid, and perform cardiopulmonary resuscitation (CPR).

In addition, we conduct periodic health and safety audits of our facilities to monitor the effectiveness of our programs and drive continuous improvement in our overall safety performance as Insulet expands in size and impact.

As part of this initiative, we have trained certain employees to use automated external defibrillators, provide first aid, and perform cardiopulmonary resuscitation (CPR).

In 2023, we implemented a text emergency system for our employee base located in our Acton headquarters and Acton manufacturing facility, which advises employees on building closures and emergencies with clear instructions.

We also conduct periodic health and safety audits of our facilities to monitor the effectiveness of our programs and drive continuous improvement in our overall safety performance as Insulet expands in size and impact.

What changed 10-K

Item 1. Business